A Randomized Controlled Trial Protocol for GeloRevoice Throat Lozenges as Adjunctive Analgesic in Post‐tonsillectomy Pain. (2nd September 2014) - Liu, Zi Wei
Abstract : Objectives: There has been recent controversy with regard to optimal postoperative pain control for tonsillectomy. Codeine is no longer recommended for children under the age of 12 years because of the risk of respiratory depression. Hence, identifying alternative/adjunct analgesia for post‐tonsillectomy pain is a high clinical priority. This is a protocol for a randomized controlled trial. The primary objective is to determine whether GeloRevoice throat lozenges (contain sodium hyaluronate) are effective as adjunct therapy to standard analgesia (paracetamol, ibuprofen, difflam spray) in post‐tonsillectomy pain. Methods: A total of 72 patients were randomized to 2 groups. Parents with children aged 6 to 18 years undergoing tonsillectomy were approached to participate in the study. The intervention group received GeloRevoice throat lozenges and the control group received a placebo. The study was subject to trust research and audit and safety reporting procedures, and ethical approval was applied for. Results: The primary endpoint was a pain score using a visual analog scale for pediatric populations. Pain scores were recorded on a diary card daily for 1 week postoperatively. Visual analog scale data were compared between 2 groups using a 2‐tailed t test where P <. 05 was considered to be statistically significant. Conclusions: This double‐blinded randomized controlled trial provides evidence on the safety and efficacy of GeloRevoice throat lozenges when used as adjunctive analgesia for post‐tonsillectomy pain.