Skip to content

A clinical trial to compare subcutaneous injection versus intravenous injection of tramadol for extremities injuries with moderate pain in the emergency department

Subcutaneous versus intravenous tramadol for extremities injuries with moderate pain in the emergency department: a randomised controlled non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15316150
Enrollment
198
Registered
2018-04-05
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain associated with extremities injuries Nervous System Diseases Pain

Interventions

198 patients are randomly assigned to two groups using a stratified block randomisation sequence method. Patients are stratified by baseline pain score (pre-intervention pain score of 4, 5 or 6 (moder

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily sign the informed consent form 2. Patients presenting with extremities injuries - defined as injuries to the upper limbs including the shoulders, and injuries to the lower limbs excluding the hip 3. Soft tissue injuries or suspected soft tissue injuries (skin abrasions, sprains, strains, ligament injuries, muscle injuries) 4. Closed fracture or suspected closed fracture 5. Moderate pain (pain score of 4, 5 or 6 using verbal numerical rating scale)

Exclusion criteria

Exclusion criteria: 1. Patients with open fractures as they will require procedural sedation for early reduction 2. Patients with laceration wounds as they will require local anaesthesia for wound suturing 3. Patients who will require admission 4. History of allergy or suspected allergy to tramadol 5. Pregnant patients 6. Patients with known liver disease 7. Patients who had consumed or had received any analgesia prior to presentation to the emergency department 8. Patients who are taking analgesia for other pathology

Design outcomes

Primary

MeasureTime frame
Pain score, as measured using verbal numerical rating scale, at 30 min after the administration of tramadol

Secondary

MeasureTime frame
1. Time from administration of tramadol to pain relief (or to decision to administer rescue analgesia) 2. Pain score associated with subcutaneous injection and intravenous cannulation 3. Incidence of any local or systemic side effects 4. Need for rescue analgesia 5. Need for anti-emetic 6. Patient's overall satisfaction using a 5-point Likert scale

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026