STUDY OBJECTIVE: To evaluate the efficacy and the quality of recovery with intravenous (IV) paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. DESIGN: Prospective, randomized, double-blinded clinical trial. SETTING:Operating room and Postanesthesia Care Unit (PACU) of a university-affiliated hospital. PATIENTS: 64 ASA physical status I and II children, aged 6 to 16 years, scheduled for adenotonsillectomy. INTERVENTIONS: All patients were premedicated with oral midazolam 0.5 mg/kg 30 minutes before surgery. Patients were randomized to two groups following induction of general anesthesia. The paracetamolgroup (n = 32) received 15 mg/kg of IV paracetamol and the tramadolgroup (n = 32) received 1.0 mg/kg of IV tramadol. MEASUREMENTS: Modified Hannallah pain scores, emergence agitation, Aldrete scores, sedation scores, time to first administration of analgesic, heart rate, and mean arterial blood pressure were recorded for each patient. Data were recorded every 5 minutes for the first 30 minutes and every 10 minutes for the remaining 30 minutes in the PACU, then at 2, 3, 4, 5, 6, 8, 12, and 24 hours in the ward. The frequency of postoperative nausea and vomiting also was noted. Satisfaction of parents and nurses was determined on a 4-point scale at the end of the study. MAIN RESULTS: No significant demographic differences between groups were noted. No statistically significant difference was found in postoperative pain scores in either group. Agitation scores, Aldrete scores, sedation scores, and number of patients who received rescue analgesia and time to administration of rescue analgesia were similar in both groups. CONCLUSIONS: The IV formulation of paracetamol was associated with similar analgesic properties and early recovery to that of IV tramadol after adenotonsillectomy in children.
RCT Entities:
STUDY OBJECTIVE: To evaluate the efficacy and the quality of recovery with intravenous (IV) paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. DESIGN: Prospective, randomized, double-blinded clinical trial. SETTING: Operating room and Postanesthesia Care Unit (PACU) of a university-affiliated hospital. PATIENTS: 64 ASA physical status I and II children, aged 6 to 16 years, scheduled for adenotonsillectomy. INTERVENTIONS: All patients were premedicated with oral midazolam 0.5 mg/kg 30 minutes before surgery. Patients were randomized to two groups following induction of general anesthesia. The paracetamol group (n = 32) received 15 mg/kg of IV paracetamol and the tramadol group (n = 32) received 1.0 mg/kg of IV tramadol. MEASUREMENTS: Modified Hannallah pain scores, emergence agitation, Aldrete scores, sedation scores, time to first administration of analgesic, heart rate, and mean arterial blood pressure were recorded for each patient. Data were recorded every 5 minutes for the first 30 minutes and every 10 minutes for the remaining 30 minutes in the PACU, then at 2, 3, 4, 5, 6, 8, 12, and 24 hours in the ward. The frequency of postoperative nausea and vomiting also was noted. Satisfaction of parents and nurses was determined on a 4-point scale at the end of the study. MAIN RESULTS: No significant demographic differences between groups were noted. No statistically significant difference was found in postoperative pain scores in either group. Agitation scores, Aldrete scores, sedation scores, and number of patients who received rescue analgesia and time to administration of rescue analgesia were similar in both groups. CONCLUSIONS: The IV formulation of paracetamol was associated with similar analgesic properties and early recovery to that of IV tramadol after adenotonsillectomy in children.