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Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

NCT ID: NCT03383315

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Opioid Analgesic Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
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.

Study Groups

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Group 1

Intravenous tramadol 50mg + intravenous metoclopramide 10mg

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

One dose of intravenous tramadol 50mg

Metoclopramide

Intervention Type DRUG

One dose of intravenous metoclopramide 10mg

Group 2

Intravenous tramadol 50mg + placebo (normal saline)

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

One dose of intravenous tramadol 50mg

Placebo

Intervention Type DRUG

Sodium chloride 0.9%

Interventions

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Tramadol

One dose of intravenous tramadol 50mg

Intervention Type DRUG

Metoclopramide

One dose of intravenous metoclopramide 10mg

Intervention Type DRUG

Placebo

Sodium chloride 0.9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Dr Choo Kim Hoon

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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NMRR-16-1688-32638

Identifier Type: -

Identifier Source: org_study_id