drugset / Trial / NCT02441673

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

NCT02441673

Phase 2 Unknown 130 enrolled Lagos State Health Service Commission
RandomizedParallel-groupTriple-blindPrevention

Summary

Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded based on it's severity and has been known to cause various problems like patient's discomfort, hypoxia, change in hemodynamic variables of the patient and poor wound healing. This problem has been managed via pharmacologic and non-pharmacologic means. Non-pharmacologic modalities involve options aimed at warming the patient. Pharmacologically, opioids are used more commonly to prevent and treat this condition. This then introduces the side effect of nausea/vomiting and sedation which may reduce overall patient's satisfaction on the perception of the Subarachnoid block. It is for this reason that Nefopam - a centrally acting non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic, relatively new drug in the Nigerian market with significant anti-shivering effect is compared with a well established opioid like Tramadol. Having similar cost profile, the option of replacing Tramadol with Nefopam especially in conditions where the patient is more hemodynamically unstable is considered in this project.

Timeline

Start
2018-10-12
Primary completion
2019-01
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nefopam Small molecule 0.15 mg/kg Intravenous
Comparator Tramadol Other / unclassified 1 mg/kg Intravenous
Comparator Ephedrine Small molecule 3 mg
Comparator Meperidine Unknown 25 mg Intravenous
Comparator Metoclopramide Small molecule 10 mg Intravenous
Comparator Oxytocin Peptide Intravenous
Comparator Ranitidine Unknown 50 mg Intravenous