Expert opinion and clinical practice recommendations using a modified Delphi approach for pediatric acute cough evaluation and management in India

ABSTRACT

Background and Objective:

Cough is the most frequently managed pediatric issue in primary care which needs simplified guidelines and algorithms for general practitioners.

Methods:

A modified Delphi method was used to reach the consensus on clinical statements and ways to assess and categorize cough. The panel comprised eight experts, including pediatric pulmonologists, pulmonologists, and pediatricians.

Results:

Out of total of 49 clinical statements 45 reached consensus in the first round. An expert panel joined in online deliberation to refine the remaining four statements. Experts recommend history taking and clinical examination as the most accurate methods for determining the cause of a child’s cough. A dry cough in children typically results from viral infections, allergies, or inhaled irritants, while a wet cough suggests bronchitis, which can be viral, allergic, or bacterial. Sputum colour is not a reliable indicator for differentiating bacterial and viral bronchitis. Multi-ingredient cough and cold medications often contain irrational formulations, increasing the risk of adverse events. Based on initial cough categorization, pediatric cough treatment should target specific symptoms with minimal ingredients. Bronchodilators are used for bronchospasm or wheezing; antihistamines should only be added for allergic symptoms. Cough expectorants help in specific situations with excess mucus. Additional insights include red flag signs, nonpharmacologic therapy, and specialist referral.

Conclusion:

The present consensus fills the existing need and will guide family physicians in successfully diagnosing and managing cough in the primary healthcare setting in India.

INTRODUCTION

Cough affects 9.6% of the global population and 5-10% of people in India.[1] It serves as a crucial natural defence mechanism for the respiratory tract. Although it is a reflex action, it can indicate various respiratory and nonrespiratory diseases.[2] It is a common reason for children to seek medical attention, often causing significant concern for parents. When prolonged, cough can disrupt daily activities or sleep, affecting children’s and caregivers’ quality of life.[3] Around 30-40% of children with cough consult a physician.[3] General practitioners (GPs) or family physicians are responsible for triaging self-limiting, prolonged, and potentially life-threatening cases. However, diagnosing cough often presents a challenge in primary care settings in India.[4] Existing algorithms and guidelines are typically designed for specialized fields, and their limited use by general practitioners leads to inadequate screening and categorization of cough, resulting in prescription of irrational fixed drug combination (FDC) formulations.[5] The widespread use of these irrational FDCs raises concerns about efficacy, safety (side effects), and potential drug interactions, as well as straining healthcare resources. To manage cough effectively, it is essential to develop a treatment plan based on an accurate diagnosis using a symptom-based approach and a thorough understanding of the underlying causes of the cough, considering various clinical parameters.[6]

Therefore, there was a need to create an integrated guidance document for managing cough, specifically aimed at primary care physicians in India. This consensus seeks to address this gap by providing clinical recommendations for diagnosing and managing cough in primary healthcare settings in India.

The modified Delphi method aimed to understand the clinical and pathophysiological differences between cough in adults and children, develop simplified guidance for general practitioners on the ways to assess and categorize, and arrive at a consensus on managing acute cough in children.[7]

MATERIALS AND METHODS

A comprehensive electronic search of PubMed/MEDLINE was conducted from 2004 to 2024, to identify relevant articles on pediatric cough evaluation, diagnosis, and management in primary care, using keywords such as auscultation, cough, pediatric population, diagnostics, complications, treatment, intervention, and management. Furthermore, studies not published in English or falling outside the mentioned period or did not focus on the diagnosis, complications, treatment, or management of pediatric cough were excluded from the review. The evidence was graded based on the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria.[8,9,10]

A multidisciplinary expert panel comprising of practicing Pediatric Pulmonologists (n = 2), Pulmonologist (n = 1) and Pediatricians (n = 5) with research involvement in pulmonology medicine and clinical expertise of minimum 10 years, formulated 49 statements on clinical management of acute cough in pediatric patients in India based on the evidence extracted from the literature review. The consensus was developed using modified Delphi methodology with anonymous votes collected electronically via a survey link using Microsoft Forms in 2024 (April to July). The consensus statements were discussed under the following domains: definition, etiology, diagnosis, and treatment [Figure 1].

Figure 1.

Modified Delphi process followed for the consensus

Consensus voting and data collection

For consensus agreement, a 5-point Likert scale (strongly agree, agree, neutral, disagree, and strongly disagree) was used. For “disagree” or “neutral” responses, participants were required to document their specific reasoning. A predetermined consensus threshold of ≥75% agreement or disagreement was established, with mandatory participation in voting on all statements. Figure 1 provides a comprehensive overview of the methodology. No formal study registration was conducted on online platforms.

The panelists’ anonymity was preserved throughout the process, with all comments being incorporated anonymously into the statements and questionnaires distributed to panelists in each round.

A research assistant calculated and entered response frequencies for each statement anonymously into a database. Out of the 49 statements, 45 statements reached consensus. Panel members discussed the remaining four statements in an online/virtual meeting (11^th June 2024) to whether retain, modify, or eliminate them from the final guideline document. Consequently, these four statements were modified and then circulated for second round of voting [Supplementary Table 1].

Supplementary Table 1.

List of Consensus statements[50,51,52,53,54,55,56,57,58,59,60,61,62,63]

SECTION 1: Pediatric cough epidemiology, definition and classification		Agreement (consensus achieved at 75%)†
1	One of the leading causes of morbidity and mortality in children worldwide is acute respiratory illnesses (11).	8/8 SA*/Agree (100%)
2	A cough is one of the most frequent ailments that children in primary care worldwide encounter (14).	8/8 SA/Agree (100%)
3	The type of cough that results from acute respiratory disease might vary depending on how the respiratory infections impact the airways (50).	7/8 SA/Agree (87.5%)
4	The standard duration for defining a child’s chronic cough is four weeks (16).	7/8 SA/Agree 87.5%
5	Coughs lasting three to eight weeks can be called extended acute coughs (17).	6/8 SA/Agree 75%
6	History taking and clinical examination are the most accurate and efficient ways to determine the cause of a child’s cough (23).	8/8 SA/Agree 100%
7	The clinical examination helps to distinguish between dry and wet cough (23).	8/8 SA/Agree 100%
8	Clinical chemistry and a chest radiograph are not required if the patient’s history and symptoms are consistent with bronchitis or a cold (23).	8/8 SA/Agree 100%
9	A recurring, ineffective cough that lasts the entire waking day but goes away when the child goes to sleep is the hallmark of habitual cough (51).	8/8 SA/Agree 100%
10	The symptoms, duration, and origin of cough in children and adults vary (52).	8/8 SA/Agree 100%
11	For children under the age of five, there is difficulty in differentiating between dry and wet cough since they do not expectorate sputum (53).	6/8 SA/Agree 75%
SECTION 2: Common causes of Pediatric cough
12	Children with dry cough typically suffer from viral infections, allergies, or inhaled irritants (54).	8/8 SA/Agree 100%
13	Children with bronchiectasis or chronic pneumonia may exhibit a prolonged productive cough (55)	8/8 SA/Agree 100%
14	As per your experience, examination of cough sounds in children must be done with diligence and utmost precision for accurate diagnosis (50).	8/8 SA/Agree 100%
15	Sputum might appear as vomitus in children under five years old who have swallowed it (54).	8/8 SA/Agree 100%
16	Occasionally, a wet cough may sound like a dry cough but be accompanied by a noisy chest (50).	7/8 SA/Agree 87.5%
17	A wet cough indicates proximal lower airway involvement, namely bronchitis, which is frequently viral, frequently allergic, and occasionally bacterial (54).	8/8 SA/Agree 100%
18	A more prevalent tachypnoea than a wet cough indicates bronchiolitis or distal lower airway involvement (54).	8/8 SA/Agree 100%
19	Post oral corticosteroid usage for a brief period, the cessation of cough indicates asthma (56).	6/8 SA/Agree 75%
SECTION 3: History taking, Examination, Cough categorization and, Cough sounds
20	Sputum colour cannot be relied on to differentiate between bacterial and viral bronchitis (57).	6/8 SA/Agree 75%
21	Conditions including congenital heart disorders, deformities, and GERD need to be ruled out when it comes to cough in the newborn age range (15).	8/8 SA/Agree 100%
22	In clinical practice, evaluating cough sounds can be subjective and based on the clinician’s experience and expertise (50).	8/8 SA/Agree 100%
23	The existing algorithms and tools for cough categorisation are typically designed for specialised fields and are not directed towards general practitioners (31).	6/8 SA/Agree 75%
SECTION 4: Management: Irrational cough formulations, Age wise Cough Treatments
24	Bronchodilators are used when children have bronchospasm or wheezing (58).	5/8 SA/Agree 62.5%
25	Primary care physicians need to pay more attention to identifying a wheeze while evaluating wet cough to avoid using empirical cough formulations, which may include bronchodilators (5).	8/8 SA/Agree 100%
26	Considering the adverse effects of bronchodilators, they should be cautiously prescribed only to patients who have wheezed on clinical examinations and not to all patients (58).	7/8 SA/Agree 87.5%
27	Cough expectorants are helpful only in specific conditions with excess mucus and facilitate easier sputum expectoration by either increasing bronchial secretions or decreasing their viscosity (43).	4/8 SA/Agree 50%
28	Antihistaminic agents are recommended only when allergy symptoms are present and not in all cough cases (31).	8/8 SA/Agree 100%
29	Antibiotics should not be used in the treatment of uncomplicated acute bronchitis (59).	7/8 SA/Agree 87.5%
30	The Indian market offers a variety of multi-ingredient cough and cold medications which include unconventional formulations and, thus, increase the risk of adverse events and associated morbidities (5).	8/8 SA/Agree 100%
31	The widespread use of these irrational FDCs not only poses doubts about the efficacy of these combinations but also raises concerns about their safety (5).	8/8 SA/Agree 100%
32	The widespread use of these irrational FDCs not only risks the possibility of drug interactions but also strains healthcare resources (5).	8/8 SA/Agree 100%
33	Most cough and cold remedies are erratic and irrational, with three to four ingredients (5).	8/8 SA/Agree 100%
34	Considering the risks associated with using multi-ingredient cough formulations, they should be avoided as a part of empirical therapy (5).	8/8 SA/Agree 100%
35	Multi-ingredient cough formulations promise fast relief but are low on efficacy (5).	6/8 SA/Agree 75%
36	Children who consume codeine may have fatal adverse effects, convulsions and fainting (42).	7/8 SA/Agree 87.5%
37	Children’s cough suppressants also include diphenhydramine, an antihistaminic drug (60).	8/8 SA/Agree 100%
38	The FDA advises against prescribing cold and cough remedies to children under two years old (61).	8/8 SA/Agree 100%
39	Advising parents to speak with their healthcare professional before administering any OTC medication is crucial.	8/8 SA/Agree 100%
40	Healthcare practitioners should refrain from providing codeine and hydrocodone cough syrups to patients under 18 years old (62).	8/8 SA/Agree 100%
41	Ambroxol is effective only in acute wet coughs in children but only in specific conditions such as cystic fibrosis and bronchiectasis, which produce thick and sticky mucus (44).	5/8 SA/Agree 62.5%
42	Guaifenesin has a favourable safety and tolerability profile in children. However, it’s useful only in conditions such as cystic fibrosis and bronchiectasis, which produce thick and sticky mucus (43).	4/8 SA/Agree 50%
43	Single-ingredient Dextromethorphan has a solid evidence base for dry cough in children (63).	7/8 SA/Agree 87.5%
44	First-line treatment of cough should be based on single or minimum-ingredient cough formulations as per the patient’s symptoms (17).	8/8 SA/Agree 100%
45	For patients with wheezing, a single-ingredient bronchodilator should be added instead of choosing a multi-ingredient formulation with bronchodilators to avoid under-dosing in the current episode and prevent future episodes. Bronchodilators are used when children have bronchospasm or wheezing (58).	8/8 SA/Agree 100%
46	Rational fixed-dose combinations increase patient adherence and clinical efficacy (5).	8/8 SA/Agree 100%
47	It is best to avoid irrational medicine combinations since they increase treatment expenses and side effects (5).	8/8 SA/Agree 100%
48	Treatment of pediatric cough should be targeted towards specific symptoms with minimal ingredients and based on initial cough categorisation.	8/8 SA/Agree 100%
49	Parental education is needed to educate them on the rationality of available multi-ingredient cough formulations to prevent their unintended side effects and subsequent irrational use.	8/8 SA/Agree 100%

^†Consensus%=[(sum of strongly agree and agree)/10] ×100; *SA – Strongly Agree

RESULTS AND DISCUSSION

Pediatric cough-epidemiology, definition, and classification

Pediatric cough is a critical clinical issue, especially in the context of acute respiratory illnesses, which are among the leading causes of child morbidity and mortality worldwide.[1,11] Cough is one of the most common reasons for Pediatric consultations. A study involving 204,912 patients indicated that cough was reported in 30% of cases, with Pediatricians noting a prevalence of 41.6% among children seen in primary care settings.[12] Consistently, another recent study conducted in 22,51,735 patients reported cough in 575,284 (25.54%) Pediatric patients.[13] The study also demonstrated a notable variation in the incidence of different types of cough; dry cough was reported in 40-80% of patients, while wet cough occurred in 50-70% of patients in India.[14,15] Another recent study reported that 4.55% of pediatric patients in India have a productive cough, 8.28% have a nonproductive cough, while a whopping 87.17% of pediatric patients have an unspecified cough.[13] This variation highlights the need to understand the diverse causes of pediatric cough, which significantly impact treatment decisions [Table 1].

Table 1.

Recommendations for cough epidemiology, definition, and classification

Statement	Agreement
One of the leading causes of morbidity and mortality in children worldwide is acute respiratory illnesses.	100%
A cough is one of the most frequent ailments that children in primary care worldwide encounter.	100%
The standard duration for defining a child’s chronic cough is 4 weeks.	87.5%
Coughs lasting 3 to 8 weeks can be called extended acute coughs.	75%
A recurring, ineffective cough that lasts the entire waking day but goes away when the child goes to sleep is the hallmark of a habitual cough.	100%
The type of cough that results from acute respiratory disease might vary depending on how the respiratory infections impact the airways.	87.5%
History taking and clinical examination are the most accurate and efficient ways to determine the cause of a child’s cough.	100%
The clinical examination helps to distinguish between dry and wet cough.	100%
Clinical chemistry and a chest radiograph are not required if the patient’s history and symptoms are consistent with bronchitis or a cold.	100%
The symptoms, duration, and origin of cough in children and adults vary.	100%

Chronic cough in children (defined as lasting for more than 4 weeks) requires thorough evaluation to avoid unnecessary treatments and guide appropriate care.[16,17] Coughs lasting for 3 to 8 weeks is classified as extended acute cough. While recurrent cough persisting for more than ten days and occurring four or more times a year, raise concerns about potential underlying chronic conditions that require further investigation.[18] While these definitions of the different types of cough align with global guidance from the American College of Chest Physicians (ACCP),[19,20] British Thoracic Society (BTS),[21] European Respiratory Society (ERS),[17] and Saudi Pediatric Pulmonology Association (SPPA),[22] that differentiate acute from chronic cough but vary in duration thresholds, ranging from <4 weeks for acute to >4-8 weeks for chronic cough, distinguishing between dry and wet coughs is particularly challenging in children under five, who often cannot expectorate sputum. This necessitates a proper diagnosis of cough in pediatric patients. It is seen that taking accurate respiratory history for coughing helps delineate the pathophysiological basis of the cause of chronic cough, especially in children.[23] Studies have shown that detailed history taking enhances the evaluation and treatment of chronic cough in children, thereby facilitating a tailored diagnostic identification of likely diagnoses of underlying cause of cough.[24,25]

Common causes of pediatric cough

It has been reported that the most prevalent causes of chronic cough in children can be grouped into nine pathological classes, ranging from postinfection, to airway infections (protracted/recurrent/persistent), airway anomaly, airway inflammation, airway aspiration, upper airway associations (rhinitis and sinusitis) and even some complicated causes like Tic and somatic syndrome, extra-pulmonary reasons and interstitial lung disease or tumors.[23] Of these, childhood postinfectious cough (typically with natural resolution over time) is a common etiology seen in children, wherein cough reflex hypersensitivity may continue for weeks after viral or bacterial infection.[18,26] The cough in this case is usually a dry cough with no other symptoms.[24] Wet cough, on the other hand, is associated with increased airway infections, airway anomalies, airway aspiration, and other less common specific diseases. Chang et al.[24] argued that wet cough is categorized as a specific cough (those that require treatment) and a nonspecific cough (likely to resolve without treatment).

A common challenge in clinical practice is the difficulty in distinguishing between dry and wet coughs in young children, particularly those under five. Collecting sputum specimens is not feasible in small children, and the risk of obtaining low-quality sputum culture is high; however, these can be obtained in older children. Furthermore, young children (<6 years) may swallow sputum, adding to diagnostic confusion.[22] Correct cough categorization is the mainstay for the right management of acute cough, and hence, simple, easy-to-use questionnaires, tools can be used at the primary care level.

The characteristic sound of cough, produced by distinct airway vibration patterns, provides critical diagnostic information regarding respiratory system function.[27] Clinicians also use cough sounds to diagnose cough in pediatric patients. The cough sounds provide information about the pathophysiological mechanisms of coughing by indicating the structural nature of the tissue and leading to certain patterns of cough. Wheezing is indicative of airway inflammation (i.e., asthma), airway anomaly (i.e., tracheomalacia), or other specific diseases.[24] It is shown that clinicians are slightly better at assessing wet or dry coughs using these subjective assessments and can be compared with bronchoscopy findings.[16] These findings suggest careful history taking and correlating it with cough types and cough sounds, as adequate, can help in proper diagnosis of cough in pediatric patients. However, the subjectivity in evaluating cough sounds should be acknowledged. This subjectivity poses challenges, especially since existing algorithms and guidelines for cough categorization are often designed for respiratory and pulmonary experts, leaving general practitioners with less precise guidance.

Sputum color is sometimes used to distinguish between bacterial and viral infections.[20] A systematic review found that sputum color has a sensitivity of 81% but a specificity of only 50% for identifying bacterial infections in acute exacerbations of chronic obstructive pulmonary disease.[28] This indicates that while it can identify some bacterial infections, it also produces a significant number of false positives. Green or yellow sputum is often associated with bacterial infections, yet these colors can also appear in viral infections, leading to misdiagnosis[29] [Table 2].

Table 2.

Recommendations for diagnosis of pediatric cough and cough categorization

Statement	Agreement
For children under the age of 5, there is difficulty in differentiating between dry and wet cough since they do not expectorate sputum.	75%
Sputum might appear as vomitus in children under 5 years old who have swallowed it.	100%
Sputum colour cannot be relied on to differentiate between bacterial and viral bronchitis.	75%
Conditions including congenital heart disorders, deformities, and GERD need to be ruled out when it comes to cough in the newborn age range.	100%
Children with dry cough typically suffer from viral infections, allergies, or inhaled irritants.	100%
Children with bronchiectasis or chronic pneumonia may exhibit a prolonged productive cough.	100%
As per the healthcare practitioners experience, examination of cough sounds in children must be done with diligence and utmost precision for accurate diagnosis.	100%
In clinical practice, evaluating cough sounds can be subjective and based on the clinician’s experience and expertise.	100%
The existing algorithms and tools for cough categorization are typically designed for specialised fields and are not directed towards general practitioners.	75%
Occasionally, a wet cough may sound like a dry cough but be accompanied by a noisy chest.	87.5%
A wet cough indicates proximal lower airway involvement, namely, bronchitis, which is frequently viral, frequently allergic, and occasionally bacterial.	100%
A more prevalent tachypnoea than a wet cough indicates bronchiolitis or distal lower airway involvement.	100%

GERD: gastroesophageal reflux disease

Another crucial point to be considered while diagnosis of cough condition in pediatric patients is ruling out pediatric GERD especially in infants. In infants, regurgitation typically reflects physiological immaturity of the gastroesophageal junction in pediatric GERD. A conservative “educate-test-treat” approach is particularly crucial in such cases as misdiagnosis may lead to over-medication in infancy and potential treatment-related adverse effects without meaningful clinical benefit.[30] Thus, it is important for physicians to rely on meticulous history-taking and physical examination in categorizing pediatric cough.

Treatment and management of pediatric cough

The irrational use of fixed-dose combinations (FDCs), common in the Indian market, is a significant concern.[5] These multi-ingredient formulations often include bronchodilators and antihistamines, which may not be necessary for all the patients and could lead to adverse effects and drug interactions.[31] The government of India has banned various irrational FDCs along with codeine based formulations particularly common in the management of acute cough. In 2008, the U.S. Food and Drug Administration recommended against the use of cough and cold medicines in children under 2 due to concerns about safety and efficacy, and the American Academy of Pediatrics advised avoiding their use in children under 6.[32] A comprehensive meta-analysis of 1992 infants in India found that bronchodilators like albuterol and salbutamol cause side effects without demonstrating substantial clinical improvements.[33] Another study noted that bronchodilators significantly impact heart rate changes, suggesting dose-dependent risks amongst pediatric patients. Clinicians should carefully weigh the potential adverse effects against therapeutic benefits when prescribing these medications.[34] The panel strongly advises against using bronchodilators without wheezing and cautions against the empirical use of such treatments in patients with wet cough [Table 3].

Table 3.

Recommendations for management of pediatric cough in Indian children[50,51,52,53,54,55,56,57,58,59,60,61,62,63]

Statement	Agreement
Postoral corticosteroid usage for a brief period, the cessation of cough indicates asthma.	75%
Bronchodilators are used when children have bronchospasm or wheezing.	100% (Round 1 62.5%)
Primary care physicians need to pay more attention to identifying wheeze while evaluating wet cough to avoid using empirical cough formulations, which may include bronchodilators.	100%
Considering the adverse effects of bronchodilators, they should be cautiously prescribed only to patients who have wheezed on clinical examinations and not to all patients.	87.5%
Cough expectorants are helpful only in specific conditions with excess mucus and facilitate easier sputum expectoration by either increasing bronchial secretions or decreasing their viscosity.	100% (Round 1 50%)
Antihistaminic agents are recommended only when allergy symptoms are present and not in all cough cases.	100%
Antibiotics should not be used in the treatment of uncomplicated acute bronchitis.	87.5%
The Indian market offers a variety of multi-ingredient cough and cold medications which include unconventional formulations and, thus, increase the risk of adverse events and associated morbidities.	100%
The widespread use of these irrational FDCs not only poses doubts about the efficacy of these combinations but also raises concerns about their safety.	100%
The widespread use of these irrational FDCs not only risks the possibility of drug interactions but also strains healthcare resources.	100%
Most cough and cold remedies are erratic and irrational, with three to four ingredients.	100%
Considering the risks associated with using multi-ingredient cough formulations, they should be avoided as a part of empirical therapy.	100%
Multi-ingredient cough formulations promise fast relief but are low on efficacy.	75%
Children who consume codeine may have fatal adverse effects, convulsions and fainting.	87.5%
Children’s cough suppressants also include diphenhydramine, an antihistaminic drug.	100%
The FDA advises against prescribing cold and cough remedies to children under two years old.	100%
Advising parents to speak with their healthcare professional before administering any OTC medication is crucial.	100%
Healthcare practitioners should refrain from providing codeine and hydrocodone cough syrups to patients under 18 years old.	100%
Ambroxol is effective only in acute wet coughs in children but only in specific conditions such as cystic fibrosis and bronchiectasis, which produce thick and sticky mucus.	100% (Round 1 62.5%)
Guaifenesin has a favourable safety and tolerability profile in children. However, it is useful only in conditions such as cystic fibrosis and bronchiectasis, which produce thick and sticky mucus.	100% (Round 1 50%)
Single-ingredient Dextromethorphan has a solid evidence base for dry cough in children.	87.5%
First-line treatment of cough should be based on single or minimum-ingredient cough formulations as per the patient’s symptoms.	100%
For patients with wheezing, a single-ingredient bronchodilator should be added instead of choosing a multi-ingredient formulation with bronchodilators to avoid under-dosing in the current episode and prevent future episodes. Bronchodilators are used when children have bronchospasm or wheezing.	100%
Rational fixed-dose combinations increase patient adherence and clinical efficacy.	100%
It is best to avoid irrational medicine combinations since they increase treatment expenses and side effects.	100%
Treatment of pediatric cough should be targeted towards specific symptoms with minimal ingredients and based on initial cough categorization.	100%
Parental education is needed to educate them on the rationality of available multi-ingredient cough formulations to prevent their unintended side effects and subsequent irrational use.	100%

Cough variant asthma and silent chest warrant referral to a pediatric specialist, who may opt for bronchodilator therapy.[35,36] However, in instances of acute cough associated with wheezing due to foreign body aspiration, bronchodilator treatment is unlikely to be effective and may not be indicated.[37] Inhaled corticosteroids are recommended as first-line therapy for asthma. However, asthma response to steroids was found to be different in adults than in children.[19] Inhaled corticosteroids are found to be effective in low doses even in children with moderate asthma who do not achieve good control with other therapies. Children with severe asthma sometimes require inhaled glucocorticosteroids in doses that are in the range of possible toxicity, but the risk of adverse effects must always be weighed against the dangers of uncontrolled asthma.[38]

Expectorants (e.g., Guaifenesin) decrease the surface tension and viscosity of mucus, facilitating easier expectoration and enhancing the removal of respiratory mucus through improved flow via ciliary action.[39] Topical mucolytics, such as normal saline, are often used for nebulizing effects in older children.[40] There is some evidence suggesting that honey may be effective in treating cough, typically administered by dissolving it in warm water.[41]

Furthermore, the risks of over-the-counter (OTC) cough medications, particularly those containing codeine or hydrocodone, are linked to severe adverse effects in children.[42] Medications such as ambroxol and guaifenesin have better-established safety profiles in pediatric populations.[43,44]

Several recent incidents in 2025 involving contaminated cough syrups in India have resulted in multiple deaths among young children, especially in Madhya Pradesh and Rajasthan. Investigations traced the fatalities to the presence of the highly toxic industrial solvent diethylene glycol (DEG) in certain batches of locally produced cough syrups. These events exposed crucial gaps in pharmaceutical quality control and highlights an urgent need for robust batch testing, as required by Indian drug regulations.[45] To address public concern and mitigate further risks, the Government of India issued new advisories in October 2025, instructing states and healthcare providers to avoid prescribing or dispensing cough and cold syrups to children under 2 years of age, and to substantially limit their use in all children below five.[46,47] The guidance emphasized that most acute cough illnesses in children are self-limiting and rarely require pharmacological intervention. It also called for stricter surveillance, reinforced batch testing for toxic products like diethylene glycol, and close adherence to proper pediatric dosing and safety protocols. Additionally, the Government is weighing making cough syrups prescription-only, removing them from over-the-counter status to reduce the risk of inadvertent or inappropriate use.[46,47] Hence, it is recommended to use the cough formulations from the companies with stringent quality controls in place.

This is the first consensus recommendation in the Indian context for diagnosis and management of acute cough in children. Active discussion during the modified Delphi methodology has generated a guidance document for primary care clinicians in diagnosing and managing cough in children, a symptom frequently seen in primary care. Although this technique adds credibility, their universal acceptance is questionable as they provide relatively lowest level of evidence[48] and are also associated with response bias among panelists due to the iterative approach.[49]

CONCLUSION

In conclusion, managing pediatric cough requires a nuanced understanding of its diverse causes and careful clinical evaluation to guide appropriate treatment. The consensus underscores the importance of distinguishing between dry and wet coughs, particularly in young children. Cough categorization is specifically important at the primary care level. The recommendations also caution against the overuse of empirical treatments like bronchodilators and multi-ingredient formulations and unnecessary use of antibiotics. Educating caregivers about the risks of certain over-the-counter medications is essential to ensure safer, more effective care for children with coughs. Stringent quality checks is mandatory for the cough formulations to be used, particularly for acute cough in children.

Conflict of interest

Nil.

Funding Statement

Nil.