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Trial record 5 of 30 for:    mahajan

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2015 by Lagos State Health Service Commission
Sponsor:
Information provided by (Responsible Party):
Sarah Beckley, Lagos State Health Service Commission
ClinicalTrials.gov Identifier:
NCT02441673
First received: May 1, 2015
Last updated: June 25, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention Phase
Post Anaesthetic Shivering
Drug: Nefopam
Drug: Tramadol
Drug: Metoclopramide
Drug: Ranitidine
Drug: Pethidine
Drug: Ephedrine
Drug: oxytocin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block

Resource links provided by NLM:


Further study details as provided by Lagos State Health Service Commission:

Primary Outcome Measures:
  • Presence of Post anaesthetic shivering measured by the Crossley and Mahajan Scale [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

    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

  • Severity of Post Anaesthetic Shivering measured by th Crossley and Mahajan Scale [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Presence of Vomiting and Retching using Observation [ Time Frame: 60minutes ] [ Designated as safety issue: No ]
    Presence or absence of vomiting or retching after administration of the intervention drug

  • Change in Mean Arterial Pressure (MAP) in mmHg [ Time Frame: 60minutes ] [ Designated as safety issue: No ]
    Blood Pressure measurement (systolic and diastolic) with the MAP would be measured every 5minutes throughout the 60minutes study duration


Estimated Enrollment: 130
Study Start Date: September 2015
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nefopam

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
Other Name: Acupan
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.
Active Comparator: Tramadol

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
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.

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  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02441673

Contacts
Contact: Sarah Beckley, MBBS,MPH,DA, +2348033086024 hijeh00@yahoo.com

Sponsors and Collaborators
Lagos State Health Service Commission
Investigators
Study Director: Maria Akintimoye Lagos State HealthService Commission
  More Information

Responsible Party: Sarah Beckley, Dr, Lagos State Health Service Commission
ClinicalTrials.gov Identifier: NCT02441673     History of Changes
Other Study ID Numbers: SAS/15/01 
Study First Received: May 1, 2015
Last Updated: June 25, 2015
Health Authority: Nigeria : West African College of Surgeons

Keywords provided by Lagos State Health Service Commission:
Postanaesthetic shivering
Subarachnoid block
Tramadol
Nefopam

Additional relevant MeSH terms:
Oxytocin
Ephedrine
Pseudoephedrine
Ranitidine
Ranitidine bismuth citrate
Metoclopramide
Meperidine
Tramadol
Nefopam
Anesthetics
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on January 17, 2017