Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children.

Fifty children (2-9 years) scheduled for tonsillectomy were enrolled in a double-blind randomized prospective study to compare postoperative analgesia provided with propacetamol/paracetamol (acetaminophen) or tramadol. A standard anaesthetic technique was used; each patient received sufentanil 0.25 microg kg(-1) intravenously followed with either i.v. propacetamol 30 mg kg(-1) or tramadol 3 mg kg(-1) before surgical incision. For postoperative analgesia, each child received either tramadol drops (2.5 mg kg(-1)) or paracetamol (acetaminophen) suppositories (15 mg kg(-1)), 6 and 12 h after surgery the first day and three times a day during postoperative days 2 and 3. This dosage of paracetamol is lower than the current recommended dosage, which is 40 mg kg(-1) loading dose followed by 20 mg kg(-1) 8 h(-1). Rescue medication consisted of i.v. diclofenac (1 mg kg(-1)) during the first six postoperative hours and oral ibuprofen (6-9 mg kg(-1)) afterwards. Postoperative pain scores (Children's Hospital of Eastern Ontario Pain Scale) in recovery, numerical pain scale in the ward and at home, and rescue analgesic use were significantly lower in the tramadol group. No serious adverse effects were observed.

RCT Entities:   Population Interventions Outcomes