OBJECTIVE: To compare the analgesic efficacy of tramadol to that of ketorolac trometamol administered intravenously and at fixed times over the 24 hours after abdominal hysterectomy. PATIENTS AND METHODS: This controlled, double blind, randomized clinical trial enrolled 76 women undergoing abdominal hysterectomies. Two treatment groups were formed: the TRA (Tramadol) group received 100 mg and the KET (Ketorolac) group 30 mg administered every 6 hours intravenously. Patients were ASA I-II and aged 35 to 65 years old. Patients were excluded from the study if hysterectomy was performed because of a tumor, or if there was a history of bleeding dyscrasias, of gastric or duodenal ulcers or of allergy to drugs in the study or if other analgesics had been used within 15 days of surgery. Analgesic efficacy was assessed using a visual analog scale (VAS) and a verbal response scale (VRS). Need for top-up analgesia was recorded, as were the number of patients withdrawing before the end of the study and the side effects attributable to treatment. RESULTS: The mean VAS score throughout the study was 3.6 for the TRA group and 4.4 for the KET group (non-significant, p = 0.05). Likewise, VRS scores were similar. In the first 12 h after surgery, VAS scores in the TRA group were statistically lower than those of the KET group (p < 0.05). Nine patients abandoned the study before it ended: 3 in group TRA and 1 in the KET group. Three withdrew in the TRA group (2 because of vomiting and 1 for administrative reasons). Six left the KET group (4 for uncontrolled pain, 1 for impossible intubation and 1 for administrative reasons. In the TRA group, 38% experienced vomiting whereas only 8% did so in the KET group. No serious postoperative complications were recorded. CONCLUSIONS: During the first 12 hours following surgery, a 100 mg dose of tramadol has been shown to provide more effective pain relief than 30 mg of ketorolac administered intravenously every 6 hours. The only drawback to administering the drug intravenously was the high incidence of postoperative vomiting.
RCT Entities:
OBJECTIVE: To compare the analgesic efficacy of tramadol to that of ketorolac trometamol administered intravenously and at fixed times over the 24 hours after abdominal hysterectomy. PATIENTS AND METHODS: This controlled, double blind, randomized clinical trial enrolled 76 women undergoing abdominal hysterectomies. Two treatment groups were formed: the TRA (Tramadol) group received 100 mg and the KET (Ketorolac) group 30 mg administered every 6 hours intravenously. Patients were ASA I-II and aged 35 to 65 years old. Patients were excluded from the study if hysterectomy was performed because of a tumor, or if there was a history of bleeding dyscrasias, of gastric or duodenal ulcers or of allergy to drugs in the study or if other analgesics had been used within 15 days of surgery. Analgesic efficacy was assessed using a visual analog scale (VAS) and a verbal response scale (VRS). Need for top-up analgesia was recorded, as were the number of patients withdrawing before the end of the study and the side effects attributable to treatment. RESULTS: The mean VAS score throughout the study was 3.6 for the TRA group and 4.4 for the KET group (non-significant, p = 0.05). Likewise, VRS scores were similar. In the first 12 h after surgery, VAS scores in the TRA group were statistically lower than those of the KET group (p < 0.05). Nine patients abandoned the study before it ended: 3 in group TRA and 1 in the KET group. Three withdrew in the TRA group (2 because of vomiting and 1 for administrative reasons). Six left the KET group (4 for uncontrolled pain, 1 for impossible intubation and 1 for administrative reasons. In the TRA group, 38% experienced vomiting whereas only 8% did so in the KET group. No serious postoperative complications were recorded. CONCLUSIONS: During the first 12 hours following surgery, a 100 mg dose of tramadol has been shown to provide more effective pain relief than 30 mg of ketorolac administered intravenously every 6 hours. The only drawback to administering the drug intravenously was the high incidence of postoperative vomiting.