Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383315
• Other study ID #: NMRR-16-1688-32638
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2017
• Last updated: December 22, 2017
• Start date: July 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Analgesic Adverse Reaction
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Tramadol
One dose of intravenous tramadol 50mg
• Metoclopramide
One dose of intravenous metoclopramide 10mg
• Placebo
Sodium chloride 0.9%

Locations

Country	Name	City	State
Malaysia	Sarawak General Hospital	Kuching	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vomiting	Number of episodes of vomiting 60 minutes after administration of study drugs	One hour