Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Opioid Analgesic Adverse Reaction
• Intervention / Treatment: Drug: Tramadol; Drug: Metoclopramide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 2

Contacts and Locations

Study Locations

• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea severity scale	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.	One hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vomiting	Number of episodes of vomiting 60 minutes after administration of study drugs	One hour

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Tramadol; Metoclopramide
• Other Study ID Numbers: NMRR-16-1688-32638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No