Table 2.
First author | Year of study | Study design | Place of study | Participants | Mean age [Range] | Gender | Condition being treated | Drug | Route of administration | Treatment duration | Adverse effects (no of events) |
---|---|---|---|---|---|---|---|---|---|---|---|
Tammara et al 18 | 2011 | Clinical trial | USA | 59 | N/A [1 month-6 years] | 64.28%B, 35.71% G | GERD | Pantoprazole (59) | Oral | 7 days (42) 28 days (17) | fever (6), diarrhea (8), gastroenteritis (3), rhinitis (3), GI infection (2), contact dermatitis (2), tooth disorder (2) vomiting (4), abdominal pain (2), nausea (2), increased cough (2), URTI (2). |
Gutiérrez-Junquera et al 19 | 2018 | Prospective cohort study | Madrid | 57 | 11 [5.5-12.8] years | 73.7% B, 26.3% G | Eosinophilic esophagitis | Esomeprazole | N/A | 12 months | diarrhea (3), abdominal pain (1), urticaria (1), headache (1) |
Duncan et al 20 | 2018 | Retrospective cohort study | USA | 293 | 8.8 months | 58.38% B, 41.62% G | Oropharyngeal dysphagia | lansoprazole, pantoprazole, omeprazole (149) | NA | 7.11 months | pneumonia, URTI, gastrointestinal infections, and sepsis |
Gremse et al 21 | 2019 | Clinical trial | USA, Poland, Portugal, Mexico) | 62 | N/A [12-17 years] | 100% B | Esophagitis | Dexlansoprazole (62) | Oral | 36 weeks | headache (14), oropharyngeal pain (6), diarrhea (4), nasopharyngitis (7), abdominal pain (8), Pharyngitis (6), URTI (4), bronchitis (3), sinusitis (1), insomnia (3), erosive esophagitis (1) |
Hassall et al 22 | 2006 | Cohort study | Canada | 166 | 8 [0.75-11.5] years | N/A | GERD, esophageal atresia | Omeprazole, lansoprazole. | NA | 3 years | nausea (2), diarrhea (1), skin rash (1), agitation (1), irritability (1), vomiting (1) |
Gunasekaran et al 23 | 2002 | Clinical trail | USA | 63 | 14.1 [12-17] years | 50.8% B, 49.2% G | GERD | Lansoprazole (63) | Oral | 5 days | peripheral edema (1), maculopapular rash (1) urticaria (1), sensitive teeth (4), diarrhea (4), dizziness (4) |
Haddad et al 24 | 2013 | Clinical trial | United States, Belgium, Denmark, France, Italy, Poland, Israel, South Africa, India | 127 | 5.7 [1-11] years | 56% B, 44% G | GERD | Rabeprazole (127) | Oral | 12 weeks | vomiting (18), (18), abdominal pain (15), diarrhea (14) |
Haddad et al 25 | 2014 | Cohort study | United States, Belgium, Denmark, France, Italy, Poland, Israel, South Africa, India | 64 | 6 [1-12] years | 57.81% B, 42.19% G | GERD | Rabeprazole | N/A | 36 weeks | URTI (8), vomiting (7), abdominal pain (5), diarrhea (4), pyrexia (3), cough (2) |
Kierkus et al 26 | 2006,2007 | Clinical trail | USA, Europe, Australia | 45 | N/A [1-11 months] | 53.3% B, 46.7% G | GERD | Pantoprazole | Oral | 5 days | anemia (4), constipation (3), vomiting (3), hypoxia (3), cough (4), rhinitis (4), fever (3), URTI (3), otitis media (3), infection (2), diarrhea (2), GERD (2), pharyngitis (2), contact dermatitis (2), eczema (2), rash (2) |
Kuhn et al 27 | 2017 | Retrospective cohort study | Pennsylvania, USA | 526 | 9.9 years | 28.1% G, 71.9% B | N/A | Proton pump inhibitors (30) | N/A | N/A | Eosinophilic esophagitis (30) |
James et al 28 | 2007 | Clinical trial | USA | 24 | 14.2 [12-16] years | 45.83% B, 54.17% G | GERD | Rabeprazole | Oral | 5-7 days | headache (4), nausea (2), asthma (1), fatigue (1), periorbital edema (1), diarrhea (1), dysmenorrhea (1), pharyngolaryngeal pain (1), proteinuria (1), polyuria (1). |
Sandström et al 29 | 2012 | Clinical trial | USA | 59 | N/A [0-17 years] | 50.8% B, 49.2%G | GERD | Esomeprazole (59) | IV | 4 days | constipation (6), pyrexia (5), erythema (3), pruritus (3), rash (3), arthralgia (3), tachycardia (3) |
Lassalle et al 30 | 2023 | Cohort study | France | 1 262 424 | N/A [1.8-6.2 years] | 53.4% B, 46.6% G | N/A | Proton pump inhibitors (606 645) | N/A | N/A | GI infections (9412), ENT infections (3700), LRTI (10 446), UTI (2798), skin infections (360), musculoskeletal system infections (203), nervous system infections (200), bacterial pathogen (3177), viral pathogen (14 598), traumatic Injuries (Excluding Fractures) (1106) |
Gilger et al 31 | 2015 | Clinical trial | Belgium, France, Italy, USA | 109 | N/A [1-11 years] | 51.4% B, 48.6% G | GERD | Esomeprazole (108) | Oral | 53.4 days | diarrhea (3), headache (2), somnolence (2), flatulence (1), nausea (1), cough (1), asthenia (1), viral infection (1), arthralgia (1). |
Kukulka et al 32 | 2011 | Clinical trial | USA | 36 | 14.6 [12-17] years | 38.9% B, 61.1% G | GERD | Dexlansoprazole (36) | Oral | 7 days | abdominal pain (4), vomiting (2), headache (1) |
Fleishman et al 33 | 2020 | Retrospective cohort study | USA | 32 001 | 4 years [6 months-15.5 years] | 52.5% B, 47.5%G | N/A | Esomeprazole, lansoprazole, pantoprazole, omeprazole (431) | NA | 2 years | Fracture (431) |
Zannikos et al 34 | 2011 | Clinical trial | US, Belgium | 28 | 6.7 [1-11] years | 57.1%B, 42.9%G | GERD | Rabeprazole (28) | oral | 5 day | vomiting (3), abdominal pain (3), diarrhea (2), hypergastrinemia (3), nausea (1), pancreatitis (1), regurgitation (1), toothache (1), volvulus (1), viral gastritis (1), streptococcus pharyngitis (2), URTI (1), cough (3), asthma (1), pyrexia (2), chills (1) |
Turco et al 35 | 2005-2009 | Case control study | Italy | 68 | N/A [1.1-17.8 years] | 50.8% B, 49.2% G | Protracted diarrhea and abdominal pain | Proton pump inhibitors (19) | N/A | N/A | Clostridium difficle infection (19) |
Righini Grunder et al 36 | 2017 | Cohort study | Montreal, Canada | 73 | 4.78 years [3.64-7.97] | 43.8% G, 56.2% B | Esophageal atresia | Proton pump inhibitors (73) | Oral | 2 weeks (43), Ongoing (30) | Regurgitation (49), eosinophilic esophagitis (15), pneumonia (15), bolus impaction (10) |
Ward et al 37 | 2010 | Clinical trial | USA | 40 | 37.9 weeks | 75% B, 25% G | GERD | Pantoprazole | Oral | ≥5 days | constipation (2), anemia (2), hypoxia (2), rhinitis (2), and contact dermatitis (2). |
Fiedorek et al 38 | 2005 | Clinical trail | United States | 87 | 14.1 [12-17] years | 39% B, 61% F | GERD | Lansoprazole (87) | Oral | 8 weeks | headache (20) abdominal pain (12), dizziness (3), asthenia (2), diarrhea (2), vomiting (2), nausea (3), anorexia (1) |
Orenstein et al 39 | 2006-07 | Clinical trial | Poland, United States | 162 | 16 [4-49] weeks | 76.9%B, 23.07% G | GERD | Lansoprazole (81) | Oral | N/A | URTI (29), dermatitis (16), Eczema (16), constipation (12), GERD (12), ear infections (including otitis media) (15), Fever (15), Diarrhea (10), Rhinorrhea (10), LRTI (11), Candidiasis (8), Viral infection (8), Vomiting (6), Ileus (1), Dehydration (1), Epididymal infection (1), Arachnoid cyst (1), Cellulitis (1), Febrile convulsion (1), Klebsiella infection (1) |
Omari et al 40 | 2007 | Clinical trial | Australia | 50 | N/A [1-24 months] | 62% B, 38% G | GERD | Esomeprazole (50) | Oral | 1 week | irritability (3), nasopharyngitis (3), vomiting (2), eczema (1), UTI (1), constipation (1), nasal congestion (1), rash (1), regurgitation (1) |
Tolia et al 41 | 2002 | Clinical trial | USA | 66 | 7 [1-11] years | 61% B, 39% G | GERD, erosive esophagitis | Lansoprazole | N/A | 8-12 week | pharyngitis (15), gastroenteritis (8), headache (7), vomiting (7) |
Tolia et al 42 | 2004, 2005 | Clinical trial | Belgium, France, Italy, and the United States | 109 | 5.7 [1-11] years | 51.3% B, 48.6% G | Erosive esophagitis | esomeprazole | oral | 8 weeks | diarrhea (3), headache (2), somnolence (2) |
Winter et al 43 | 2010 | Clinical trial | United States,Canada, Europe, South Africa | 106 | 4.9 [1-11] months | 65.38% B, 34.61% G | GERD | Pantoprazole (52) | Oral | 4 weeks | URTI (7), rash (4), ↑CPK (3), otitis media (3), vomiting (3), diarrhea (2), cough (2), laryngitis 2 |
Winter et al 44 | 2015 | Clinical trial | United States, France, Germany, Poland | 98 | 4.9 [1-11] months | 76.9% B, 23.07% G | GERD | Esomeprazole (39) | Oral | 2 weeks | URTI (6), pyrexia (5), rhinitis (4), diarrhea (4), nasopharyngitis (23) |
Yanqin Li et al 45 | 2020 | Cohort study | China | 42 232 | 6.2 years [1 month-18 years] | 39% B, 61% G | All hospitalized pediatric patients | Proton pump inhibitors (11 496) | Oral | N/A | Hospital-acquired Acute Kidney Injury (HA-AKI) (962) |
Wang et al 46 | 2021 | Cohort study | Sweden | 80 870 | 12.9 [1-17] years | 37% B, 63% G | N/A | Omeprazole (65 860), Esomeprazole (11 305), Pantoprazole (821), Lansoprazole (3219), Rabeprazole (6) | N/A | 3 years | Asthma (4428) [Omeprazole, 2854; Esomeprazole, 1250; Pantoprazole, 37; Lansoprazole, 305] |
Wang et al 47 | 2022 | Cohort study | Sweden | 29 320 | 11.9 [7-17] years | 40.3% B, 59.7% G | N/A | Omeprazole (25 061), Esomeprazole (3328), Pantoprazole (209), Lansoprazole (865), Rabeprazole (0) | N/A | 1.6 years | Depression (273), Anxiety (432) [Esomeprazole, 97; Omeprazole, 843] |
Abbreviations: B, boys; G, girls; URTI, upper respiratory tract infection; LRTI, lower respiratory tract infection; UTI, urinary tract infection; CPK, creatinine phosphokinase.