Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

• Sponsor: University of Malaya (Other)
• Overall Status: Completed
• CT.gov ID: NCT03383315
• Collaborator: (none)
• Enrollment: 191
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 63.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma; Opioid Analgesic Adverse Reaction	Drug: Tramadol; Drug: Metoclopramide; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Sep 30, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Vomiting [One hour]

   Number of episodes of vomiting 60 minutes after administration of study drugs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarawak General Hospital	Kuching	Sarawak	Malaysia	93586

Sponsors and Collaborators

• University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Choo Kim Hoon, Doctor, University of Malaya
• ClinicalTrials.gov Identifier: NCT03383315
• Other Study ID Numbers: NMRR-16-1688-32638
• First Posted: Dec 26, 2017
• Last Update Posted: Dec 26, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries; Tramadol; Metoclopramide

Study Results

No Results Posted as of Dec 26, 2017