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Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03383315
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Information provided by (Responsible Party):
Dr Choo Kim Hoon, University of Malaya

Brief Summary:
Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.

Condition or disease Intervention/treatment Phase
Trauma Opioid Analgesic Adverse Reaction Drug: Tramadol Drug: Metoclopramide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The study drugs were prepared under sterile conditions by a pharmacist independent to the study and kept in packs.The patients recruited were randomized to receive one of the study packs. The study pack were numbered by the pharmacist, who used a computer-generated random number sequence to assign treatment allocations. The allocation list was kept by the pharmacist. Treatment allocations were revealed only after study completion, when all outcome measurements had been performed and recorded by the investigator in the study database.
Primary Purpose: Prevention
Official Title: Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1
Intravenous tramadol 50mg + intravenous metoclopramide 10mg
Drug: Tramadol
One dose of intravenous tramadol 50mg

Drug: Metoclopramide
One dose of intravenous metoclopramide 10mg

Active Comparator: Group 2
Intravenous tramadol 50mg + placebo (normal saline)
Drug: Tramadol
One dose of intravenous tramadol 50mg

Drug: Placebo
Sodium chloride 0.9%

Primary Outcome Measures :
  1. Nausea severity scale [ Time Frame: One hour ]
    Change in rating of nausea severity on Visual Analogue Scale 60 minutes after administration of the study drugs. VAS is a standard 100mm line marked "no nausea" at the left end and "worst nausea imaginable" at the right end. Minimum clinically significant difference is defined for this study as 20 mm increment.

Secondary Outcome Measures :
  1. Vomiting [ Time Frame: One hour ]
    Number of episodes of vomiting 60 minutes after administration of study drugs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years or older on day of presentation to ETD SGH
  • Sustained from traumatic injuries of extremities (Fracture of hand & wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot & ankle; laceration wounds of extremities; soft tissue injury)
  • Patient who is able to give consent

Exclusion Criteria:

  • Known allergy to metoclopramide
  • Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
  • A history of vomiting since time of injury
  • Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
  • Below age of 18 on day of presentation, or patients who could not consent to the study
  • Any alteration in level of consciousness
  • Hemodynamic instability or primary diagnosis requiring time critical intervention
  • Pregnancy or lactation
  • History or known case of vertiginous disorder
  • Currently undergoing chemotherapy or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03383315

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Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Sponsors and Collaborators
University of Malaya

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Responsible Party: Dr Choo Kim Hoon, Doctor, University of Malaya Identifier: NCT03383315    
Other Study ID Numbers: NMRR-16-1688-32638
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action