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 |
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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 |