Somri 2012.
Methods | Parallel design Funding: not stated Location: Israel |
|
Participants | Inclusion criteria: patients unable to tolerate dental treatment under behavioural management and local anaesthetic or in combination with nitrous oxide use n = 90 Age range = 3 to 10 years Mean age (SD) in years, weight (SD) in kg: Group 1: 5.6 + 1.85, 19.2 + 3.68 Group 2: 5.6 + 1.67, 19.7 + 3.38 Group 3: 6.2 + 2.00, 20.3 + 3.65 |
|
Interventions | Group 1: midazolam (0.5 mg/kg) Group 2: midazolam (0.75 mg/kg) Group 3: midazolam (1 mg/kg) All orally |
|
Outcomes | Wisconsin sedation scale, Houpt behavioural rating scale, parent satisfaction | |
Notes | Immobilisation with manual restraining used Wisconsin level 5 (deep sedation) considered adequate All children received 2 litres of oxygen during treatment |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomly assigned by sealed envelope technique" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding ‐ Participant | Unclear risk | Not described |
Blinding ‐ Operator/sedationist | Low risk | Nursing staff administering the midazolam, specialist paediatric dentist and anaesthetist performing procedure and post‐operative discharge nurses were blinded |
Blinding ‐ Outcome assessor | Unclear risk | Not described if the assessor was blinded |
Incomplete outcome assessment | Low risk | All participants included in the outcome evaluation |
Free of selective reporting | Low risk | All planned outcomes reported |
Free of other bias | Low risk | No other bias |