Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

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.

Conditions

• Post Anaesthetic Shivering

Interventions

DRUG

Nefopam

Nefopam 0.15mg/kg would be made up to 10mls using sterile water for injection

DRUG

Tramadol

Tramadol 1mg/kg would be made up to 10mls using sterile water for injection

DRUG

Metoclopramide

10mg would be given morning of surgery as a prokinetic premedication for all patients.

DRUG

Ranitidine

50mg would be given to each patient morning of surgery as a premedicant to reduce the acidity of the gastric contents. It is routine for CS.

DRUG

Pethidine

25mg would be used to stop shivering where a repeat dose of the primary intervention drugs have not been effective.

DRUG

Ephedrine

A vasopressor. Would be used to combat any hypotension that occurs due to the neuroaxial block. Would be used in aliquots of 3mg.

DRUG

oxytocin

Would be used for all patients following delivery of the baby to aid contraction of the uterus.

Sponsors & Collaborators

• Lagos State Health Service Commission

  lead OTHER

Principal Investigators

• Maria Akintimoye · Lagos State HealthService Commission

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-12

Primary Completion

2019-01-31

Completion

2019-06-30