Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Effect of ketorolac on bleeding time and postoperative pain in children: a double-blind, placebo-controlled comparison with meperidine.

STUDY OBJECTIVE: To determine whether ketorolac 0.75 mg/kg would provide a comparable degree of analgesia to that of meperidine 1 mg/kg in terms of postoperative opioid requirements and pain scores in children undergoing surgeries associated with mild to moderate postsurgical discomfort.

DESIGN: Randomized, prospective, placebo-controlled, double-blinded study of the initial 6 postsurgical hours.

SETTING: University affiliated teaching hospital.

PATIENTS: 90 healthy ASA status I and II children scheduled for elective general, orthopedic, or genitourinary procedures associated with mild to moderate postsurgical pain. Extensive surgical procedures associated with a significant risk of bleeding were excluded.

INTERVENTIONS: Ketorolac 0.75 mg/kg, meperidine 1 mg/kg, or placebo (normal saline) was administered intramuscularly (IM) at the beginning of surgery.

MEASUREMENTS AND MAIN RESULTS: Bleeding times were measured prior to and 180 minutes after study drug administration. Time to first rescue medication, total opioid requirement, pain scores, incidence of vomiting and length of stay were evaluated. Placebo-treated patients were rescued earlier (p < 0.0001) and required twice the rescue dosage (p = 0.013) when compared with either the ketorolac or meperidine groups. The ketorolac and meperidine groups did not differ with regard to time until first rescue, cumulative proportion requiring rescue, or the number of rescue doses required. A single dose of IM ketorolac prolonged bleeding time by 53 +/- 75 seconds (p = 0.006).

CONCLUSIONS: Ketorolac provided analgesia comparable to that of meperidine and significantly reduced opioid requirements. Since ketorolac was not associated with a reduction in postoperative vomiting or length of stay, and in view of the uncertain risk of bleeding, it offers no advantage over meperidine in the management of mild to moderate acute postsurgical pain.

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