A double-blind evaluation of ketorolac tromethamine versus acetaminophen in pediatric tonsillectomy: analgesia and bleeding.

The study was designed to compare intravenous ketorolac to rectal acetaminophen for analgesia and bleeding in pediatric patients undergoing tonsillectomy. We studied 50 patients, aged 2-15 yr undergoing tonsillectomy with or without adenoidectomy. In a randomized, prospective double-blind fashion, patients were assigned to receive either ketorolac (1 mg/kg) or rectal acetaminophen (35 mg/kg). Bleeding was evaluated by measuring intraoperative blood loss and noting extra measures required to obtain hemostasis. Bleeding times were also measured before and during surgery. Pain was evaluated using a standard objective pain score for the first 3 h. Persistent pain was treated with morphine, acetaminophen, and codeine and recorded for 24 h. Blood for determination of acetaminophen levels was drawn at 20 and 40 min after the administration of study drugs. Pain scores were not significantly different between the ketorolac and acetaminophen groups. The majority of patients in both groups required additional opioid in the postoperative period. Acetaminophen levels were all less than the therapeutic range. Intraoperative bleeding times were normal in all patients, but blood loss was significantly higher in the ketorolac group (2.67 mL/kg) compared to the acetaminophen group (1.44 mL/kg), P = 0.025. Significantly more measures to achieve hemostasis were required in the ketorolac group (P = 0.012). We conclude that ketorolac is no more effective than high-dose rectal acetaminophen for analgesia in the patient undergoing tonsillectomy. Hemostasis during tonsillectomy was significantly more difficult to achieve in patients receiving ketorolac.

Single-blind comparative analgesic and safety study of single doses of intramuscularly administered ketorolac tromethamine and pethidine hydrochloride in patients with pain following orthopaedic surgery.

Ketorolac tromethamine, a potent non-narcotic prostaglandin synthetase inhibiting analgesic was compared with pethidine for relief of moderate to severe postoperative pain. Forty-eight patients received Ketorolac 0.5 mg/kg and 52 received pethidine 1.25 mg/kg. The degree of pain prior to the administration of the drug and pain relief that followed were quantified using a vertical visual analogue scale (VAS) and monitored at hourly intervals. The safety profile was also studied by recording all adverse events noted. The mean pain (VAS) score at medication for Ketorolac was 7.04 and for pethidine 7.09. The pain relief obtained in the first four hours following administration of the drugs was similar for pethidine and Ketorolac. Although Ketorolac showed a longer sustained pain relief, time to peak analgesia after administration of this drug was slower than that after pethidine. It took 30 to 50 min for pethidine compared to 75 to 150 min for Ketorolac to achieve peak analgesia. The latter is therefore inappropriate if rapid pain relief is required. The incidence of side effects was significantly greater with pethidine (40.4%) as compared to Ketorolac (10.4%). The similar analgesic efficacy to pethidine makes Ketorolac an appropriate drug for the relief of postoperative pain especially in day surgery settings where observation following administration of the drug as in the case of pethidine can be dispensed with and patients sent home earlier because of the minimal side effects associated with its use. Caution must be exercised with the use of large doses of Ketorolac especially if the drug is used for more than 5 days to avoid serious complications like renal failure and gastrointestinal bleeding.

Enhancement of pain control with ketorolac tromethamine in patients with sickle cell vaso-occlusive crisis.

Twenty one patients with sickle cell disease admitted to the hospital with the pain of vaso-occlusive crisis (VOC) were treated by continuous IV infusion of ketorolac or normal saline for up to 5 days. All patients received supplemental IM injections of meperidine, 100 mg, as necessary, but not more frequently than every 3 hr. Over the 5 days the ketorolac treated patients (KT) required 33% less meperidine than did the placebo treated patients (PL), P = 0.04, and had significantly better pain relief as assessed by categorical, visual analog, and pain relief scales. By the end of 5 days infusions had been discontinued in six KT and one PL. The time to discontinuation of the infusion was significantly shorter in KT, (P = 0.009). The median duration of hospital stay from the start of treatment was 3.3 days for KT and 7.2 days for PL, P = 0.027. Adverse events were mainly related to the digestive system. This study showed that continuous infusion of ketorolac significantly reduced total meperidine requirement and that the analgesia produced by this combination was superior to that produced by meperidine alone. Further evaluation of this drug in the management of sickle cell VOC is warranted.

Comparison of intravenous ketorolac tromethamine and morphine sulfate in the treatment of postoperative pain.

This study compared the efficacy and safety of ketorolac tromethamine and morphine sulfate in alleviating moderate or severe pain immediately after major surgery. One hundred twenty-two patients were randomly assigned to receive single intravenous injections of ketorolac 10 mg, ketorolac 30 mg, morphine 2 mg, or morphine 4 mg; patients could receive a second dose 15 minutes thereafter, upon request, and most received both available doses. Analgesic efficacy was measured by interviewing patients and assessing pain intensity and pain relief for 6 hours after the first medication administration. The two drugs showed a similar onset of action, peaking 1 hour after administration. When placed in order of descending efficacy, the mean scores for most efficacy measures fell into the following sequence: ketorolac 30 mg, ketorolac 10 mg, morphine 4 mg, and morphine 2 mg. There were no statistically significant differences among the two ketorolac doses and the high dose of morphine, but all three of these treatments were significantly superior to the low morphine dose. One patient who took morphine 4 mg withdrew because of drowsiness; other common adverse events reported included nausea, vomiting, somnolence, and dyspepsia. There were no statistically significant differences in the frequency of adverse events among the treatment groups. Intravenous ketorolac is effective for the treatment of postoperative pain.