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Completed

NCT Number: NCT03383315

Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

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.

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Key information

Conditions

Trauma Opioid Analgesic Adverse Reaction Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

One dose of intravenous tramadol 50mg

Metoclopramide

Drug

One dose of intravenous metoclopramide 10mg

Placebo

Drug

Sodium chloride 0.9%

Primary outcomes

  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 outcomes

  1. Vomiting

    Time frame: One hour

    Number of episodes of vomiting 60 minutes after administration of study drugs

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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