CONTEXT: Poisoning with organophosphorus (OP) compounds constitutes a global public health problem. Standard treatment of OP poisoning involves use of atropine and pralidoxime. While efficacy of atropine is well-established, clinical experience with pralidoxime in management of OP poisoning is controversial. AIMS: To explore the efficacy of add-on pralidoxime with atropine over atropine alone in the management of OP poisoning. SETTINGS AND DESIGN: An open-label, parallel-group, randomized clinical trial was conducted in a tertiary care district hospital in West Bengal. MATERIALS AND METHODS:Patients presenting with features of OP poisoning were randomly allocated to receive atropine or atropine-plus-pralidoxime. Efficacy was assessed by analyzing mortality, requirement for ventilator support and the duration of stay in hospital. STATISTICAL ANALYSIS: Chi-square test was done to compare the efficacy parameters between the two groups. A two-tailed P-value <0.05 was considered as statistically significant. RESULTS: During the study period, 150 patients were screened following which 120 patients were randomized to either of the treatment arms. Add-on pralidoxime therapy did not offer any appreciable benefit over atropine alone in terms of reducing mortality (18.33% (11/60) versus 13.33% (8/60)) and ventilator requirement (5% (3/60) versus 8.33% (5/60)). However, patients randomized in the add-on pralidoxime arm experienced longer duration of hospital stay (7.02 ± 1.12 days) than those receiving atropine-alone therapy (5.68 ± 1.87 days) (P < 0.001). CONCLUSION: The present study suggested that add-on pralidoxime with atropine therapy did not offer any appreciable benefit over atropine alone in management of OP poisoning. However, further trials are needed to explore different dosing regimens of pralidoxime in order to determine its efficacy in OP poisoning.
RCT Entities:
CONTEXT: Poisoning with organophosphorus (OP) compounds constitutes a global public health problem. Standard treatment of OP poisoning involves use of atropine and pralidoxime. While efficacy of atropine is well-established, clinical experience with pralidoxime in management of OP poisoning is controversial. AIMS: To explore the efficacy of add-on pralidoxime with atropine over atropine alone in the management of OP poisoning. SETTINGS AND DESIGN: An open-label, parallel-group, randomized clinical trial was conducted in a tertiary care district hospital in West Bengal. MATERIALS AND METHODS:Patients presenting with features of OP poisoning were randomly allocated to receive atropine or atropine-plus-pralidoxime. Efficacy was assessed by analyzing mortality, requirement for ventilator support and the duration of stay in hospital. STATISTICAL ANALYSIS: Chi-square test was done to compare the efficacy parameters between the two groups. A two-tailed P-value <0.05 was considered as statistically significant. RESULTS: During the study period, 150 patients were screened following which 120 patients were randomized to either of the treatment arms. Add-on pralidoxime therapy did not offer any appreciable benefit over atropine alone in terms of reducing mortality (18.33% (11/60) versus 13.33% (8/60)) and ventilator requirement (5% (3/60) versus 8.33% (5/60)). However, patients randomized in the add-on pralidoxime arm experienced longer duration of hospital stay (7.02 ± 1.12 days) than those receiving atropine-alone therapy (5.68 ± 1.87 days) (P < 0.001). CONCLUSION: The present study suggested that add-on pralidoxime with atropine therapy did not offer any appreciable benefit over atropine alone in management of OP poisoning. However, further trials are needed to explore different dosing regimens of pralidoxime in order to determine its efficacy in OP poisoning.