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Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy.
OBJECTIVE: To determine if pretonsillectomy injection of local anesthetics with and without clonidine reduces pain following tonsillectomy in children.
DESIGN: A prospective, randomized, double-blind, placebo-controlled trial.
SETTING: Tertiary care academic medical center.
PATIENTS: A total of 120 children, ages 3 to 17 years, presenting for tonsillectomy.
INTERVENTIONS: Patients were randomized to 1 of 3 pretonsillectomy injection groups: (1) saline, (2) lidocaine plus bupivacaine, or (3) lidocaine plus bupivacaine plus clonidine.
MAIN OUTCOME MEASURES: The total number of analgesic doses consumed on postoperative days (PODs) 1, 3, 5, and 7. Secondary outcome variables included total time and intravenous analgesic doses required in the recovery room, visual analog scale pain scores, and maximum tolerated diet on postoperative days 1, 3, 5, and 7.
RESULTS: The total number of analgesic doses on PODs 1, 3, 5, and 7 were not significantly different between the randomization groups (P = .53). The median numbers (interquartile ranges) of analgesic doses were 12.0 (9.0-16.8) for the lidocaine plus bupivacaine plus clonidine group, 12.0 (10.0-16.5) for the lidocaine plus bupivacaine group, and 14.0 (9.0-15) for the placebo group. The placebo group was found to have a more advanced diet on POD 1 (P = .04) and significantly less pain on POD 3 (P = .02). Multivariable analysis showed children in the lidocaine plus bupivacaine plus clonidine group were significantly less likely to need intravenous pain medication in the recovery room compared with children in the placebo group and again showed that the placebo group achieved a significantly more advanced diet and had less pain on PODs 1 and 3.
CONCLUSION: Pretonsillectomy injection of lidocaine, 1%, and bupivacaine, 0.5%, with or without clonidine (25 μg) is not recommended for the reduction of posttonsillectomy pain.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00678379.
DESIGN: A prospective, randomized, double-blind, placebo-controlled trial.
SETTING: Tertiary care academic medical center.
PATIENTS: A total of 120 children, ages 3 to 17 years, presenting for tonsillectomy.
INTERVENTIONS: Patients were randomized to 1 of 3 pretonsillectomy injection groups: (1) saline, (2) lidocaine plus bupivacaine, or (3) lidocaine plus bupivacaine plus clonidine.
MAIN OUTCOME MEASURES: The total number of analgesic doses consumed on postoperative days (PODs) 1, 3, 5, and 7. Secondary outcome variables included total time and intravenous analgesic doses required in the recovery room, visual analog scale pain scores, and maximum tolerated diet on postoperative days 1, 3, 5, and 7.
RESULTS: The total number of analgesic doses on PODs 1, 3, 5, and 7 were not significantly different between the randomization groups (P = .53). The median numbers (interquartile ranges) of analgesic doses were 12.0 (9.0-16.8) for the lidocaine plus bupivacaine plus clonidine group, 12.0 (10.0-16.5) for the lidocaine plus bupivacaine group, and 14.0 (9.0-15) for the placebo group. The placebo group was found to have a more advanced diet on POD 1 (P = .04) and significantly less pain on POD 3 (P = .02). Multivariable analysis showed children in the lidocaine plus bupivacaine plus clonidine group were significantly less likely to need intravenous pain medication in the recovery room compared with children in the placebo group and again showed that the placebo group achieved a significantly more advanced diet and had less pain on PODs 1 and 3.
CONCLUSION: Pretonsillectomy injection of lidocaine, 1%, and bupivacaine, 0.5%, with or without clonidine (25 μg) is not recommended for the reduction of posttonsillectomy pain.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00678379.
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