Intravenous indomethacin as postoperative analgesic in children: acute effects on blood pressure, heart rate, body temperature and bleeding.

To study the effect of intravenous indomethacin on blood pressure, heart rate, body temperature and post-operative bleeding we performed a double-blind, placebo-controlled study on 100 operated children, aged 1-16 years. At the end of operation intravenous indomethacin 0.35 mg/kg followed by an infusion of 0.07 mg/kg/h for 24 h combined with standard doses of morphine according to clinical needs resulted in better postoperative analgesia than morphine alone. During the two first hours the systolic and diastolic blood pressure and ventilation rate did not differ between the groups. The heart rate was significantly lower (p less than 0.001) in the indomethacin group. Indomethacin did not prolong the bleeding time. Mild to moderate bleeding was observed in 13 indomethacin--and five placebo-treated patients (p less than 0.05). The bleeding did not, however, require any intervention. The mean body temperature did not differ between the two groups in the evening following the operation, but was significantly lower (p less than 0.01) on the first postoperative morning in the indomethacin group. Six patients (12%) in the placebo group had fever over 38 degrees C and paracetamol was administered to four of them. Clinically diminished diuresis was not observed. Since prophylactic indomethacin infusion improves the postoperative analgesia in children and no clinically important unwanted effects were seen, it may be used in children, over one year of age in whom non-steroidal anti-inflammatory drugs are not contraindicated.

RCT Entities:   Population Interventions Outcomes