OBJECTIVE: To compare the efficacy of intravenous versus intramuscular antivenom (AV) in the treatment of Red-back spider (RBS) envenoming. METHODS: Randomized, double-dummy, double-blind, multicentre trial of patients with red-back spider envenoming requiring AV treatment recruited from five hospital EDs in Western Australia. RESULTS:Thirty-five patients were recruited; two were excluded; 33 were available for initial analysis, but two who were unblinded after one ampoule of trial AV and given i.v. AV had limited data; 31 remained in the study and had more complete data. After AV, pain scores for both i.m. and i.v. groups improved rapidly. At 24 h, the i.v. group was better with a 55% absolute difference (76% vs. 21%; 95% CI 25-85% difference) in the proportion pain-free. There were no safety issues. CONCLUSIONS:Red-back spider antivenom was initially effective by both i.m. and i.v. routes. The study generates the hypothesis that at 24 h, significantly more patients are pain-free with i.v. administration. Definitive recommendations on the optimal route of administration of RBS AV await the results of further studies.
RCT Entities:
OBJECTIVE: To compare the efficacy of intravenous versus intramuscular antivenom (AV) in the treatment of Red-back spider (RBS) envenoming. METHODS: Randomized, double-dummy, double-blind, multicentre trial of patients with red-back spider envenoming requiring AV treatment recruited from five hospital EDs in Western Australia. RESULTS: Thirty-five patients were recruited; two were excluded; 33 were available for initial analysis, but two who were unblinded after one ampoule of trial AV and given i.v. AV had limited data; 31 remained in the study and had more complete data. After AV, pain scores for both i.m. and i.v. groups improved rapidly. At 24 h, the i.v. group was better with a 55% absolute difference (76% vs. 21%; 95% CI 25-85% difference) in the proportion pain-free. There were no safety issues. CONCLUSIONS: Red-back spider antivenom was initially effective by both i.m. and i.v. routes. The study generates the hypothesis that at 24 h, significantly more patients are pain-free with i.v. administration. Definitive recommendations on the optimal route of administration of RBS AV await the results of further studies.
Authors: Geoffrey K Isbister; Margaret O'Leary; Mark Miller; Simon G A Brown; Sharmaine Ramasamy; Rosemary James; Jennifer S Schneider Journal: Br J Clin Pharmacol Date: 2007-08-09 Impact factor: 4.335