Background: Different parenteral routes of administration of NSAIDs such as ketoprofen have not been properly compared in children. This study was designed to compare the analgesic efficacy of intravenous and intramuscular ketoprofen for pain management in children after day-case adenoidectomy.
Methods: A total of 120 children, aged 1-9 years, who were scheduled to undergo adenoidectomy, were randomized to receive ketoprofen 2 mg/kg either intravenously with intramuscular placebo (n = 40) or ketoprofen 2 mg/kg intramuscularly with intravenous placebo (n = 40), or both intravenous and intramuscular placebo (n = 40) at induction of anesthesia. The study design was prospective and double-blind with parallel groups. Pain was assessed at rest and during swallowing using the Maunuksela pain scale during 3 h after surgery, and fentanyl i.v. was given for rescue analgesia.
Results: Children in the Placebo group needed significantly more doses of fentanyl (72 doses) than either children in the intravenous group (47 doses) or children in the intramuscular group (51 doses) (P = 0.021). In addition, a higher proportion of children in the Placebo group than in the two ketoprofen groups (P = 0.03) demanded rescue analgesic. No difference in the need for rescue analgesia or in pain scores was found between the two ketoprofen groups. Children in the intravenous group had less pain than children in the Placebo group. The difference was significant during swallowing at 1 h after surgery (P = 0.046) and for the worst pain observed during swallowing for 3 h after surgery (P = 0.022). There were no differences between the three groups with respect to operation times, amount of perioperative bleeding, or rate or extent of adverse events.
Conclusion: The efficacy of intravenous and intramuscular ketoprofen was similar, and they both differed from placebo.