Torahiko Terui1, Masaaki Inomata. 1. Department of Gastroenterology and Hepatology, Iwate Medical University, Morioka, Japan.
Abstract
AIM: The aim of the present study was to evaluate the efficacy and safety of giving pentazocine as an analgesic with benzodiazepine during endoscopic retrograde cholangiopancreatography (ERCP). METHODS: The paradoxical reactions (PR) incidence was evaluated as an indicator of usefulness. Transcutaneous arterial carbon dioxide tension (PtcCO(2) ) was evaluated as an indicator of safety. A total of 160 patients were enrolled. Subjects were randomly divided into two groups; group 1 sedated with midazolam only and group 2 sedated both with midazolam and pentazocine (7.5 mg). RESULTS: The initial dosage introduced sedation before procedure was significantly higher in group 1. The occurrence rate of PR's in group 1 was significantly higher compared to that in group 2 (P = 0.0108). Although maximum PtcCO(2) observed during sedation did not differ between the two groups (48.7 ± 7.2, 50.3 ± 7.6 mmHg, respectively),maximum PtcCO(2) during the first 15 min after the start of sedation was significantly higher in group 2 than in group 1 (P = 0.0294). In multivariate analysis, procedure duration (odds ratio [OR] = 1.048) and midazolam dose (OR = 1.221) were predictive factors for PR. CONCLUSION: The administration of pentazocine is significantly reduced the incidence of PR's in patients under midazolam induced sedation during ERCP.
RCT Entities:
AIM: The aim of the present study was to evaluate the efficacy and safety of giving pentazocine as an analgesic with benzodiazepine during endoscopic retrograde cholangiopancreatography (ERCP). METHODS: The paradoxical reactions (PR) incidence was evaluated as an indicator of usefulness. Transcutaneous arterial carbon dioxide tension (PtcCO(2) ) was evaluated as an indicator of safety. A total of 160 patients were enrolled. Subjects were randomly divided into two groups; group 1 sedated with midazolam only and group 2 sedated both with midazolam and pentazocine (7.5 mg). RESULTS: The initial dosage introduced sedation before procedure was significantly higher in group 1. The occurrence rate of PR's in group 1 was significantly higher compared to that in group 2 (P = 0.0108). Although maximum PtcCO(2) observed during sedation did not differ between the two groups (48.7 ± 7.2, 50.3 ± 7.6 mmHg, respectively),maximum PtcCO(2) during the first 15 min after the start of sedation was significantly higher in group 2 than in group 1 (P = 0.0294). In multivariate analysis, procedure duration (odds ratio [OR] = 1.048) and midazolam dose (OR = 1.221) were predictive factors for PR. CONCLUSION: The administration of pentazocine is significantly reduced the incidence of PR's in patients under midazolam induced sedation during ERCP.