Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

University of Malaya

Status and phase: Completed; Phase 2

Conditions: Opioid Analgesic Adverse Reaction; Trauma

Treatments: Drug: Tramadol; Drug: Placebo; Drug: Metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT03383315

NMRR-16-1688-32638

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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191 participants in 2 patient groups

Group 1

Experimental group

Description:

Intravenous tramadol 50mg + intravenous metoclopramide 10mg

Treatment:

Drug: Metoclopramide

Drug: Tramadol

Group 2

Active Comparator group

Description:

Intravenous tramadol 50mg + placebo (normal saline)

Treatment:

Drug: Placebo

Drug: Tramadol