Schmidt 2007.
Methods | Randomized open‐label trial | |
Participants | ASA I‐II children, 7‐12 years old, undergoing general or combined general/regional anaesthesia for various surgeries. Sixty (60) children enrolled (clonidine 18; dexmedetomidine 20; midazolam 22) Exclusions: chronic pain, cerebral palsy, autism, difficulty understanding verbal commands, preoperative use of analgesics or anticonvulsants, pre‐anaesthesia medications prior to evaluation | |
Interventions | Experimental group (1): clonidine 4 μg/kg orally, 90 min before surgery Experimental group (2): dexmedetomidine 1 μg/kg transmucosally, 45 min before surgery Comparison group: midazolam 0.5 mg/kg orally, 30 min before surgery | |
Outcomes | Pain by verbal pain scale (reported as categorical data: numbers with none, mild, moderate or severe pain)
Pain by visual analogue scale (categorically as none‐mild and moderate‐severe, and as continuous data for average score)
Sedation
Anxiety
Time to discharge from PACU Recovery time Mean arterial pressure and heart rate |
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Notes | Children received regional blocks pre‐incision according to routine: individual numbers not specified but overall rates of blockade for each treatment group given as a percentage The data from the dexmedetomidine group have not been included in this review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random list |
Allocation concealment (selection bias) | Low risk | Described as concealed by communication with principal author |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants' data analysed |
Selective reporting (reporting bias) | Unclear risk | Analgesic use was reportedly recorded, but this does not appear in Results section |
Other bias | Unclear risk | None evident; patient demographics, type of surgery, and use of regional anaesthesia evenly distributed between groups |