Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in pain severity/score
Study Overview
Brief Summary
The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.
Detailed Description
Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department.
recently Iv Paracetamol has become available in European countries and also in Iran.
efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation.
Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of acute limb trauma
- •Age>=18 years
- •Acute pain of score 3 or greater on visual analogue scale
Exclusion Criteria
- •Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
- •Known sensitivity to opioids or paracetamol
- •Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
- •Previous administration of analgesic during 6 hours ago
- •Pregnant women
- •previous inclusion to the study
- •diagnosed heart failure
- •renal failure
- •pulmonary failure or hepatic failure
Arms & Interventions
IV Paracetamol
Intervention: Paracetamol (Drug)
IV Morphine Sulfate
Intervention: Paracetamol (Drug)
Outcomes
Primary Outcomes
Change in pain severity/score
Time Frame: after 30 minutes
Secondary Outcomes
- Need for rescue analgesia(After 30 minutes)