Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

NCT02441673 | Unknown Phase 2

• 1 other identifier: SAS/15/01
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Postanaesthetic shivering; Subarachnoid block; Tramadol; Nefopam

Outcome Measures

Primary Outcomes (2)

• Presence of Post anaesthetic shivering measured by the Crossley and Mahajan Scale

  Presence of shivering following the subarachnoid block using the Crossley and Mahajan Scale 0 = no shivering 1. = no visible muscle activity but piloerection, peripheral vasoconstriction or both are present (other causes excluded) 2. = muscular activity in only one muscle group 3. = moderate muscular activity in more than one muscle group but no generalized shaking 4. = muscular activity that involves the whole body

  60 minutes

• Severity of Post Anaesthetic Shivering measured by th Crossley and Mahajan Scale

  Severity of shivering where it occurs using the Crossley and Mahajan Scale 0 = no shivering 1. = no visible muscle activity but piloerection, peripheral vasoconstriction or both are present (other causes excluded) 2. = muscular activity in only one muscle group 3. = moderate muscular activity in more than one muscle group but no generalized shaking 4. = muscular activity that involves the whole body

  60 minutes

Secondary Outcomes (2)

• Presence of Vomiting and Retching using Observation

  60minutes

• Change in Mean Arterial Pressure (MAP) in mmHg

  60minutes

Study Arms (2)

Nefopam

ACTIVE COMPARATOR

Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients. 0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for. IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.

Drug: Nefopam; Drug: Metoclopramide; Drug: Ranitidine; Drug: Pethidine; Drug: Ephedrine; Drug: oxytocin

Tramadol

ACTIVE COMPARATOR

Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients. 1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for. IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.

Drug: Tramadol; Drug: Metoclopramide; Drug: Ranitidine; Drug: Pethidine; Drug: Ephedrine; Drug: oxytocin

Interventions

Nefopam DRUG

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

Also known as: Acupan

Nefopam

Tramadol DRUG

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

Tramadol

Metoclopramide DRUG

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

Nefopam; Tramadol

Ranitidine DRUG

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.

Nefopam; Tramadol

Pethidine DRUG

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

Nefopam; Tramadol

Ephedrine DRUG

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

Nefopam; Tramadol

oxytocin DRUG

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

Nefopam; Tramadol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lagos State Health Service Commission: lead

MeSH Terms

Interventions

Nefopam; Tramadol; Metoclopramide; Ranitidine; Meperidine; Ephedrine; Oxytocin

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Furans; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Propanolamines; Amino Alcohols; Propanols; Phenethylamines; Ethylamines; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maria Akintimoye

  Lagos State HealthService Commission

  STUDY DIRECTOR

Central Study Contacts

Sarah Beckley, MBBS,MPH,DA,

CONTACT

+2348033086024; hijeh00@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 12, 2015
• Study Start: October 12, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 17, 2018

Record last verified: 2018-07