Opioid Analgesic Adverse Reaction, Trauma
Conditions
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.
Interventions
DRUGTramadol
One dose of intravenous tramadol 50mg
DRUGMetoclopramide
One dose of intravenous metoclopramide 10mg
DRUGPlacebo
Sodium chloride 0.9%
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Vomiting | One hour | Number of episodes of vomiting 60 minutes after administration of study drugs |
Countries
Malaysia
Outcome results
None listed