Table 1.
Randomized, controlled clinical trials on pediatric dental sedation (2011–2016).
| Citation | Participants | Sedative regime | Dental procedure | Behavioral outcomes | Results/conclusions |
|---|---|---|---|---|---|
| Malhotra et al., 2016 [3] | 36 children, 3–9 years old | MK: saline IN and midazolam (0.5 mg/kg) PO with ketamine (5 mg/kg) mixed in mango juice DX: dexmedetomidine (1 μg/kg) IN and mango juice C: saline IN and mango juice |
Unclear | Sedation level and behavior score (modified observer assessment of alertness and sedation, MOAAS) Ease of treatment completion (Houpt scale) |
MK: 75.0% patients successfully sedated; DX, 53.9%; C, none Houpt scores were higher in MK than DX |
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| Flores-Castillo et al., 2015 [4] | 13 children, 17–46 months old |
A: midazolam (0.4 mg/kg) SC B: midazolam-ketamine (0.4 and 0.1 mg/kg) SC |
Procedures with local anesthesia | Behavior (modified Houpt scale) | Group A: 53.85% (no cry and no movement) Group B: 69.23% (cry and movement that not interfere with treatment) |
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| Salem et al., 2015 [5] | 88 children, 4–7 years old |
Midazolam (0.2 or 0.5 mg/kg) PO A: PO formulation B: IV formulation |
Pulp therapy in primary molars | Behavior (North Carolina and Houpt scale) | Acceptable behavior in 90.9% (A) and 79.5% (B) |
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| Mahmoud and Haggag, 2014 [6] | 30 children, 4–8 years old |
A: dexmedetomidine (2.5 mcg/kg) PO B: midazolam (0.5 mg/kg) PO |
Procedures with local anesthesia | Behavior (modified Houpt scale) | Median Houpt scores were 4 (A) and 3 (B) |
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| Ghajari et al., 2014 [7] | 16 children, 2–6 years old |
A: midazolam (0.5 mg/kg) + hydroxyzine (1 mg/kg) PO B: chloral hydrate (50 mg/kg) + hydroxyzine (1 mg/kg) PO |
Not cited | Behavior (Houpt scale) | Groups differed in sedation success: A: 64.3%; B: 33.3% |
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| Natarajan Surendar et al., 2014 [8] | 84 children, 4–14 years old |
D1: dexmedetomidine (1 mcg/kg) IN D2: dexmedetomidine (1.5 mcg/kg) IN M1: midazolam (0.2 mg/kg) IN K1: ketamine (5 mg/kg) IN |
Teeth extractions | Behavior (author's scale) Pain (the FLACC Pain Assessment Tool) |
Success: D2 (85.7%), D1 (81%), K1 (66.7%), M1 (61.9%) |
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| Sheta et al., 2014 [9] | 72 children, 3–6 years old |
A: midazolam (0.2 mg/kg) IN B: dexmedetomidine (1 µg/kg) IN |
Dental rehabilitation | Sedation status (no specific scale) | Children sedation: A: 44.4% B: 77.8% |
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| Azevedo et al., 2013 [10] | 10 children, 2–4 years old |
Midazolam in different doses (0.2 to 0.4 mg/kg) PO placebo PO |
Dental rehabilitation | Behavior (Frankl scale), Adequacy of sedation (Ramsay scale) | All midazolam doses allowed positive behavior and longer appointments Midazolam: 58.1% Placebo: 31.0% |
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| Chopra et al., 2013 [11] | 30 children, 2–8 years old |
A: midazolam (0.25 mg/kg) MB spray B: midazolam (0.25 mg/kg) IN |
Procedure with local anesthesia | Behavior (Houpt scale) Acceptability of administration route |
The acceptance in A was better than in B. There was no difference in behavior scores |
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| Mittal et al., 2013 [12] | 40 children, 2–6 years old |
Premedication: midazolam (0.5 mg/kg) PO Intervention: A: propofol (1–1.5 mg/kg) IV B: ketofol (1–1.5 mg/kg midazolam + 0.25 mg/kg ketamine) IV Maintenance: propofol (25–75 mg/kg/min) IV (bolus if needed) |
Pulpectomy in primary molars | Behavior: procedural success, operator satisfaction, quality of sedation Also duration of treatment, recovery time, total dose of propofol |
Other analysis showed no behavior differences between groups |
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| Moreira et al., 2013 [13] | 41 children, <3 years old |
A: midazolam (0.5 mg/kg) PO + ketamine (3 mg/kg) PO B: midazolam (1.0 mg/kg) PO C: placebo PO |
Procedures under local anesthesia and protective stabilization | Behavior (OSUBRS) | Group A was associated with more cooperative behavior and a longer session |
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| Toomarian et al., 2013 [1] | 30 children, 2–6 years old |
Crossover design hydroxyzine (1 mg/kg) PO associated with: A: meperidine (2 mg/kg) PO B: meperidine (1 mg/kg) SM C: midazolam 0.5 mg/kg PO |
Pulp therapy in primary teeth | Behavior (Houpt and modified Houpt) | Success rates: A: 46.7%; B: 50%; C: 26.7% Patients ≥ 4 years old had six times greater chance of success |
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| Tyagi et al., 2013 [14] | 40 children, 2–6 years old |
Parallel design A: midazolam (0.5 mg) PO B: diazepam (0.5 mg) PO C: midazolam (0.06 mg/kg) IV D: placebo PO |
Restorations, pulp therapy, extractions, local anesthesia when necessary | Behavioral changes (Houpt scale) | Groups A and B: Similar sedative effects. Group C showed better scores in behavior. Group D: more negative behavior Midazolam was better than diazepam |
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| Collado et al., 2013 [15] | 98 patients, 7–15 years old |
A: patients with intellectual disability (ID, 33) B: Dentally anxious patients (DA, 44) Midazolam (0.3 to 0.5 mg/kg) IV with or without inhalation sedation (50% N2O/O2) |
Not cited | Success rate, level of cooperation (Venham), level of sedation (Ramsay scale) | In patients with DA and ID, more sessions were conducted with a totally relaxed patient (Venham score of 0) Success rate: A: 89.1% B: 90.6% |
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| Bhatnagar et al., 2012 [16] | 60 children, 3–9 years old |
Parallel design A: midazolam (0.5 mg/kg) PO B: tramadol (2 mg/kg) PO C: triclofos (70 mg/kg) PO D: zolpidem (0.4 mg/kg) PO |
Not cited | Level of sedation (no scale) and ease of handling | Groups A and B achieved better levels of sedation. D showed worse cooperation. Midazolam produced the best results, similar to tramadol |
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| Guelmann et al., 2012 [17] | 17 children, 5–8 years old |
A: discontinuation of nitrous oxide after local anesthesia (100% O2) B: Constant nitrous oxide (50% de N2O/50% O2) |
Restorative procedures, lower arch | Behavior (OSUBRS) | There were no differences between groups |
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| Somri et al., 2012 [18] | 90 children, 3–10 years old |
Midazolam PO administered in one of 3 doses: A: 0.5 mg/kg B: 0.75 mg/kg C: 1 mg/kg |
General procedures | Behavior (Houpt scale) Sedation level (Wisconsin sedation scale) Completion of procedures |
Sedation scores, cooperation, completion of the procedure were higher in B and C than in A |
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| Bahetwar et al., 2011 [19] | 45 children, 2–6 years old |
A: midazolam (0.3 mg/kg) IN B: ketamine (6 mg/kg) IN C: midazolam + ketamine (0.2 mg/kg; 4 mg/kg) IN |
Procedures under local anesthesia (infiltrative or block) | Success of treatment | Quicker sedation onset in B Success rates: A: 69.0%; B: 89.0%; C: 84.0% |
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| Pandey et al., 2011 [2] | 34 children, 2–6 years old |
Ketamine (6 mg/kg) IN administered with atomizer (A) and dropper (B) |
Procedures under local anesthesia (infiltrative or block) | Success of sedation, behavior during administration and treatment, onset, sedation depth, recovery time | Sedation was successful in 84% (B) to 95% (A) Group A had quicker onset and recovery time after sedation |
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| Shabbir et al., 2011 [20] | 12 children, 3–9 years old |
A: triclofos (70 mg/kg) PO B: midazolam (0.5 mg/kg) PO |
Procedures under local anesthesia | Behavior (Houpt scale) | Midazolam was more efficacious than triclofos |
IN = intranasal route; IV = intravenous route; MB = buccal route; SM = submucous route; PO = oral route; SC = subcutaneous route; OSUBRS = Ohio State University Behavioral Rating Scale; N2O = nitrous oxide; O2 = oxygen.