TraumaPhase 2NCT03383315
Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients
A Phase 2 study testing Tramadol and Metoclopramide in people with Trauma and Opioid Analgesic Adverse Reaction, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Opioid Analgesic Adverse Reaction
- What is being tested?
- Tramadol and Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2017to 30 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
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.
- Conditions
- Trauma, Opioid Analgesic Adverse Reaction
- Being tested
- Tramadol, Metoclopramide, Placebo
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
One dose of intravenous tramadol 50mg
MetoclopramideDrug
One dose of intravenous metoclopramide 10mg
PlaceboDrug
Sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Intravenous tramadol 50mg + intravenous metoclopramide 10mg Receives: Drug: Tramadol; Drug: Metoclopramide |
| Group 2 | Active comparator | Intravenous tramadol 50mg + placebo (normal saline) Receives: Drug: Tramadol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour
Secondary outcomes (1)
Vomiting
Number of episodes of vomiting 60 minutes after administration of study drugs
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Choo Kim Hoon, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383315
- Sponsor's protocol ID
- NMRR-16-1688-32638
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients: A Randomised, Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03383315
- Acronym / sponsor ID
- NMRR-16-1688-32638
- Conditions
- Trauma, Opioid Analgesic Adverse Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients are randomized into two groups. One group receives tramadol and metoclopramide, while another group receives tramadol and placebo (normal saline).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Tramadol, Drug: MetoclopramideIntravenous tramadol 50mg + intravenous metoclopramide 10mg |
| Group 2 | Active comparator | Drug: Tramadol, Drug: PlaceboIntravenous tramadol 50mg + placebo (normal saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolOne dose of intravenous tramadol 50mg | Drug | Group 1, Group 2 |
| MetoclopramideOne dose of intravenous metoclopramide 10mg | Drug | Group 1 |
| PlaceboSodium chloride 0.9% | Drug | Group 2 |
Primary outcome
Nausea severity scale
Time frame: 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.
1 secondary outcome
Vomiting
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol and Metoclopramide in people with Trauma and Opioid Analgesic Adverse Reaction, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea severity scale (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.