Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Phase 2

Completed

• Conditions: Trauma; Opioid Analgesic Adverse Reaction
• Interventions: Drug: Tramadol; Drug: Placebo; Drug: Metoclopramide

• Registration Number: NCT03383315
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	Intravenous tramadol 50mg + placebo (normal saline)
Group 1	Tramadol	Intravenous tramadol 50mg + intravenous metoclopramide 10mg
Group 1	Metoclopramide	Intravenous tramadol 50mg + intravenous metoclopramide 10mg
Group 2	Tramadol	Intravenous tramadol 50mg + placebo (normal saline)

Primary Outcome Measures

Name	Time	Method
Nausea severity scale	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 Outcome Measures

Name	Time	Method
Vomiting	One hour	Number of episodes of vomiting 60 minutes after administration of study drugs

Trial Locations

Locations (1)

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia