AIM: To compare diazepam use, muscle spasm, analgesia, and side effects when clonidine or fentanyl are added to epidural bupivacaine in children with cerebral palsy after multilevel orthopaedic surgery. METHOD:Fifty children were prospectively randomized to receive clonidine (n=24, mean age 10y 10mo [SD 2y 11mo]) or fentanyl (n=26, mean age 10y 11mo [SD 2y 10mo]). RESULTS: There was no difference in primary outcome measures: median diazepam use (fentanyl 0, interquartile range [IQR] 0-0; clonidine 0, IQR 0-0; p=0.46), any muscle spasm (no muscle spasms in: fentanyl, 36%; clonidine, 62%; p=0.11), painful muscle spasm (fentanyl 40%; clonidine 25%; p=0.46), or pain score ≥6 (none: fentanyl 44%; clonidine 42%; p=0.29). There were differences in secondary outcome measures: no vomiting (clonidine 63%; fentanyl 20%); vomiting occurred more frequently with fentanyl (32% vomited more than three times; clonidine none; p=0.001). Fentanyl resulted in more oxygen desaturation (at least two episodes: fentanyl 20%; clonidine 0; p<0.001). Clonidine resulted in lower mean (SD) area under the curve for systolic blood pressure (fentanyl 106.5 [11.0]; clonidine 95.7mmHg [7.9]) and heart rate (fentanyl 104.9 beats per minute [13.6]; clonidine 85.3 [11.5]; p<0.001). INTERPRETATION:Clonidine and fentanyl provide adequate analgesia with low rates of muscle spasm, resulting in low diazepam use. The choice of epidural additive should be based upon the most tolerable side-effect profile.
RCT Entities:
AIM: To compare diazepam use, muscle spasm, analgesia, and side effects when clonidine or fentanyl are added to epidural bupivacaine in children with cerebral palsy after multilevel orthopaedic surgery. METHOD: Fifty children were prospectively randomized to receive clonidine (n=24, mean age 10y 10mo [SD 2y 11mo]) or fentanyl (n=26, mean age 10y 11mo [SD 2y 10mo]). RESULTS: There was no difference in primary outcome measures: median diazepam use (fentanyl 0, interquartile range [IQR] 0-0; clonidine 0, IQR 0-0; p=0.46), any muscle spasm (no muscle spasms in: fentanyl, 36%; clonidine, 62%; p=0.11), painful muscle spasm (fentanyl 40%; clonidine 25%; p=0.46), or pain score ≥6 (none: fentanyl 44%; clonidine 42%; p=0.29). There were differences in secondary outcome measures: no vomiting (clonidine 63%; fentanyl 20%); vomiting occurred more frequently with fentanyl (32% vomited more than three times; clonidine none; p=0.001). Fentanyl resulted in more oxygen desaturation (at least two episodes: fentanyl 20%; clonidine 0; p<0.001). Clonidine resulted in lower mean (SD) area under the curve for systolic blood pressure (fentanyl 106.5 [11.0]; clonidine 95.7mmHg [7.9]) and heart rate (fentanyl 104.9 beats per minute [13.6]; clonidine 85.3 [11.5]; p<0.001). INTERPRETATION:Clonidine and fentanyl provide adequate analgesia with low rates of muscle spasm, resulting in low diazepam use. The choice of epidural additive should be based upon the most tolerable side-effect profile.