Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Study Overview
=================
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.

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

Conditions
-----------------
Trauma, Opioid Analgesic Adverse Reaction

Intervention / Treatment
-----------------
* Drug: Tramadol
* Drug: Metoclopramide
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Intravenous tramadol 50mg + intravenous metoclopramide 10mg | Drug: Tramadol<br>* One dose of intravenous tramadol 50mg<br>Drug: Metoclopramide<br>* One dose of intravenous metoclopramide 10mg<br>|
| Active Comparator: Group 2<br>Intravenous tramadol 50mg + placebo (normal saline) | Drug: Tramadol<br>* One dose of intravenous tramadol 50mg<br>Drug: Placebo<br>* Sodium chloride 0.9%<br>|

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 |