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. 2014 Jan 28;2014(1):CD009633. doi: 10.1002/14651858.CD009633.pub2

Reimer 1998.

Methods Randomized, controlled, double‐blinded study
Participants ASA I‐II children from 7‐12 years old, undergoing adenotonsillectomy. 41 enrolled but only 36 in final analysis. Removals due to breach of protocol (3); inability to cooperate with VAS due to ADD (1) and bronchospasm on extubation requiring adrenaline nebuliser (1)
 Exclusions: inability to understand English, contraindications to any of the medications in the study, obesity (weight > 90th percentile by nomogram), inability to use a visual analogue scale, use of any preoperative sedative, hypnotic or analgesic medications
Interventions Clonidine group: clonidine 4 μg/kg orally to maximum 200 μg, 60‐90 min preoperatively; then intravenous placebo immediately post‐induction
 Fentanyl group: placebo orally, 60‐90 min preoperatively; then intravenous fentanyl 3 μg/kg immediately post‐induction
Outcomes Patients receiving morphine (0.05 mg/kg) in PACU
 Total morphine given
 Number of morphine doses given
 Number receiving codeine and/or paracetamol (acetaminophen) in day care unit
 Vomiting within 24 hours
 Use of analgesia post‐discharge
 
 Excessive sedation
Also measured preoperative anxiety and sedation scores, satisfaction scores, and vital signs
Notes Local anaesthetic infiltration of tonsillar bed by surgeon prior to incision
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers, done by pharmacy
Allocation concealment (selection bias) Low risk Sealed envelopes. Randomization code kept by pharmacy; also held in sealed envelopes by one investigator in case the information was needed after hours
Blinding (performance bias and detection bias) 
 All outcomes Low risk All parties, including anaesthetist, patient, and observer blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients included in the analysis
Selective reporting (reporting bias) Unclear risk None evident
Other bias Low risk None apparent; patient demographics and surgery type distributed evenly between groups