Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial.

BackgroundThe ShangRing is a disposable, collar clamp circumcision device pre-qualified for use in men and boys 13 years and above. It has been shown to be faster than conventional circumcision with comparable adverse event (AE) rates and high client satisfaction. Voluntary medical male circumcision (VMMC) has been shown to dramatically reduce the risk of HIV acquisition in males. However, the fear of pain during circumcision is an important barrier to uptake. Use of topical anesthesia thus presents an opportunity to address this.ObjectivesWe sought to evaluate the safety, effectiveness and acceptability of the use of topical anaesthesia with ShangRing circumcision of men and boys 10 years of age and above.MethodsParticipants were randomised 2:1 to receive topical or injectable anaesthesia. All participants underwent no-flip ShangRing circumcision. The primary outcome measure was pain. Secondary outcomes included ease of use of topical versus injectable anaesthesia, AEs and participant satisfaction.ResultsCompared to the topical group, participants in the injectable group reported significantly more pain on administration of the anesthesia and at approximately 20 minutes after the procedure. In the topical group, sufficient anaesthesia with topical cream was not achieved in 21 (9.3%) cases before the start of the procedure; in another 6 (2.6%), supplementary injectable anaesthesia was required as the circumcision was being carried out. The AE rate was significantly lower (pConclusionsOur results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of the use of topical anaesthesia in ShangRing circumcision using the no-flip technique. Topical anaesthesia effectively eliminates needlestick pain from the clients' VMMC experience and thus has the potential to increase demand for the service.Trial registrationClinicalTrials.gov NCT02390310