OBJECTIVE: In this randomized prospective study, we evaluated postoperative morbidity after use of the Harmonic Scalpel (HS), an ultrasonic dissector coagulator (Ethicon Endo-Surgery Inc, Cincinnati, OH), or conventional electrocautery (EC) during tonsillectomy. STUDY DESIGN AND SETTINGS: Pediatric subjects at 2 sites were randomized and underwent tonsillectomy. Intraoperative blood loss and operation duration were recorded. Postoperative parameters and complications were recorded. RESULTS:One hundred seventeen subjects completed the study. For the HS group, mean operative time was significantly longer (P < 0.001), but intraoperative blood loss was equivalent (P = 1.000). HS subjects slept soundly on postoperative days 1, 2, 3, and 14 (P = 0.041, 0.013, 0.022, and 0.038, respectively, compared with EC group). Mean postoperative pain scores trended lower for HS subjects on postoperative days 2, 3, and 4. CONCLUSION: The use of the HS in pediatric tonsillectomy showed no increase in intraoperative or postoperative blood loss compared with the use of EC, and HS provided possible clinical advantages over EC in patient comfort. SIGNIFICANCE: Tonsillectomy subjects in the HS group showed a statistically significant ability to sleep soundly, suggesting that the subjects experienced less pain. These data correlate with the observed decrease in pain scores.
RCT Entities:
OBJECTIVE: In this randomized prospective study, we evaluated postoperative morbidity after use of the Harmonic Scalpel (HS), an ultrasonic dissector coagulator (Ethicon Endo-Surgery Inc, Cincinnati, OH), or conventional electrocautery (EC) during tonsillectomy. STUDY DESIGN AND SETTINGS: Pediatric subjects at 2 sites were randomized and underwent tonsillectomy. Intraoperative blood loss and operation duration were recorded. Postoperative parameters and complications were recorded. RESULTS: One hundred seventeen subjects completed the study. For the HS group, mean operative time was significantly longer (P < 0.001), but intraoperative blood loss was equivalent (P = 1.000). HS subjects slept soundly on postoperative days 1, 2, 3, and 14 (P = 0.041, 0.013, 0.022, and 0.038, respectively, compared with EC group). Mean postoperative pain scores trended lower for HS subjects on postoperative days 2, 3, and 4. CONCLUSION: The use of the HS in pediatric tonsillectomy showed no increase in intraoperative or postoperative blood loss compared with the use of EC, and HS provided possible clinical advantages over EC in patient comfort. SIGNIFICANCE: Tonsillectomy subjects in the HS group showed a statistically significant ability to sleep soundly, suggesting that the subjects experienced less pain. These data correlate with the observed decrease in pain scores.
Authors: David O Francis; Christopher Fonnesbeck; Nila Sathe; Melissa McPheeters; Shanthi Krishnaswami; Sivakumar Chinnadurai Journal: Otolaryngol Head Neck Surg Date: 2017-01-17 Impact factor: 3.497
Authors: Dieter K Fritz; T Wayne Matthews; Shamir P Chandarana; Steven C Nakoneshny; Joseph C Dort Journal: J Otolaryngol Head Neck Surg Date: 2016-11-08