Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lagos State Health Service Commission
• Treatments: Anesthetics; Ephedrine; Meperidine; Metoclopramide; Nefopam; Oxytocin; Pseudoephedrine; Ranitidine; Ranitidine bismuth citrate; Tramadol

Criteria

Inclusion Criteria:

• Female Patients

• Aged 18 to 45 years.

• American Society of Anesthesiologists (ASA) physical status II or III

• Caesarean Sessions (CS) amenable to Subarachnoid block

• Written informed consent

Exclusion Criteria:

• Patients who refuse to sign consent

• Patients with thyroid diseases

• Patients with cardiopulmonary diseases

• Patients with neuromuscular diseases or psychological disorders

• Patients prior on narcotics, sedatives, misoprostol or any medication likely to alter thermoregulation

• Patients with recent history of febrile illness

• Patients with history of malignant hyperthermia