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Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Primary Purpose

Trauma, Opioid Analgesic Adverse Reaction

Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Tramadol
Metoclopramide
Placebo
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sarawak General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Intravenous tramadol 50mg + intravenous metoclopramide 10mg

Intravenous tramadol 50mg + placebo (normal saline)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2017
Last Updated
December 22, 2017
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03383315
Brief Title
Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients
Official Title
Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Opioid Analgesic Adverse Reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Intravenous tramadol 50mg + intravenous metoclopramide 10mg
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Intravenous tramadol 50mg + placebo (normal saline)
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
One dose of intravenous tramadol 50mg
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
One dose of intravenous metoclopramide 10mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride 0.9%
Primary Outcome Measure Information:
Title
Nausea severity scale
Description
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.
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Vomiting
Description
Number of episodes of vomiting 60 minutes after administration of study drugs
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

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