Sequential randomised and double blind trial of promethazine prophylaxis against early anaphylactic reactions to antivenom for bothrops snake bites.

OBJECTIVE To investigate the efficacy of the H1 antihistamine promethazine against early anaphylactic reactions to antivenom. DESIGN Sequential randomised, double blind, placebo controlled trial. SETTING Public hospital in a venom research institute, São Paulo, Brazil. PARTICIPANTS 101 patients requiring antivenom treatment after being bitten by bothrops snakes. INTERVENTION Intramuscular injection of promethazine (25 mg for adults and 0.5/kg for children) or placebo given 15-20 min before starting intravenous infusion of antivenom. MAIN OUTCOME MEASURES Incidence and severity of anaphylactic reactions occurring within 24 hours after antivenom. RESULTS Reactions occurred in 12 of 49 patients treated with promethazine (24%) and in 13 of 52 given placebo (25%); most were mild or moderate. Continuous sequential analysis indicated that the study could be interrupted at the 22nd untied pair, without preference for promethazine or placebo. CONCLUSION Prophylaxis with promethazine does not prevent early reactions. Patients should be observed carefully during antivenom infusion and the subsequent few hours.