Mikawa 1996.
Methods | Randomized, placebo‐controlled trial; anaesthetists, patients and observers blinded to treatment | |
Participants | ASA I children from 5‐12 years old, undergoing minor surgery (ophthalmic, otological or urological). Ninety (90) children divided into 3 groups of 30: one group for placebo, the others for two different doses of clonidine No exclusion criteria given | |
Interventions | Clonidine 2 μg/kg or Clonidine 4 μg/kg or Control: placebo All premedications given in apple juice, 105 min before estimated time of induction of anaesthesia. Atropine 0.03 mg/kg in apple juice given to all children 60 min before estimated time of induction | |
Outcomes | Pain by Objective Pain Scale; presented as overall highest OPS score
Number of children requiring rescue analgesia (diclofenac suppository) in the first 12 hours after surgery
Number of children pain‐free in the first 12 hours after surgery
Sedation score Perioperative vital signs also recorded at various points throughout course of anaesthesia, surgery and recovery Time to extubation Time to eye opening Time to obeying commands Postoperative recovery score (Aldrete) on return to ward |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomized" but method not given |
Allocation concealment (selection bias) | Unclear risk | Not given |
Blinding (performance bias and detection bias) All outcomes | Low risk | Anaesthetist and observers blinded to group assignment; premedication or placebo given to patient in apple juice so patient appears also to have been blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients appear to have been included |
Selective reporting (reporting bias) | Unclear risk | None evident |
Other bias | Low risk | None evident; patient demographics and types of surgery are evenly distributed among between groups |