OBJECTIVES: To determine whether FloSeal as a haemostatic agent in tonsillectomy is associated with less postoperative pain than conventional haemostasis with ligatures. DESIGN: Randomised, controlled, single-blinded pilot study. SETTING: James Cook University Hospital, Middlesbrough, Cleveland, UK. PARTICIPANTS: Thirty patients over 16 years of age undergoing tonsillectomy for recurrent tonsillitis were recruited for the study. At surgery both tonsils were removed by cold steel dissection. Following randomisation one tonsil fossa had FloSeal applied and the other ligatures for haemostasis. MAIN OUTCOME MEASURES: The primary outcome measure was postoperative pain following tonsillectomy measured on a visual analogue scale. Pain was recorded three times a day for the first 10 days following surgery. Haemorrhage rates were also recorded as a secondary outcome. RESULTS: Complete data was analysed for 26 patients (87%). The data was grouped into distinct time periods: 0-2, 3-6 and 7-10 days. The sum of the visual linear analogue scale over the time periods for each patient was calculated. Using Wilcoxon Signed Ranks Test, the data was analysed and it was found that there was no statistically significant difference in postoperative pain scores between the control and treatment side at any time. There was a postoperative reactionary haemorrhage rate of 6.7% on the FloSeal side. CONCLUSION: In our pilot study there was no reduction in pain on the FloSeal side in the first 10 days following tonsillectomy which contrasts with previous findings in the literature.
RCT Entities:
OBJECTIVES: To determine whether FloSeal as a haemostatic agent in tonsillectomy is associated with less postoperative pain than conventional haemostasis with ligatures. DESIGN: Randomised, controlled, single-blinded pilot study. SETTING: James Cook University Hospital, Middlesbrough, Cleveland, UK. PARTICIPANTS: Thirty patients over 16 years of age undergoing tonsillectomy for recurrent tonsillitis were recruited for the study. At surgery both tonsils were removed by cold steel dissection. Following randomisation one tonsil fossa had FloSeal applied and the other ligatures for haemostasis. MAIN OUTCOME MEASURES: The primary outcome measure was postoperative pain following tonsillectomy measured on a visual analogue scale. Pain was recorded three times a day for the first 10 days following surgery. Haemorrhage rates were also recorded as a secondary outcome. RESULTS: Complete data was analysed for 26 patients (87%). The data was grouped into distinct time periods: 0-2, 3-6 and 7-10 days. The sum of the visual linear analogue scale over the time periods for each patient was calculated. Using Wilcoxon Signed Ranks Test, the data was analysed and it was found that there was no statistically significant difference in postoperative pain scores between the control and treatment side at any time. There was a postoperative reactionary haemorrhage rate of 6.7% on the FloSeal side. CONCLUSION: In our pilot study there was no reduction in pain on the FloSeal side in the first 10 days following tonsillectomy which contrasts with previous findings in the literature.