- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01465984
Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 1417613151
- TUMS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IV Paracetamol
|
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
|
Active Comparator: IV Morphine Sulfate
|
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pain severity/score
Time Frame: after 30 minutes
|
after 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for rescue analgesia
Time Frame: After 30 minutes
|
After 30 minutes
|
Collaborators and Investigators
Investigators
- Study Director: Mohammad Jalili, MD, TUMS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACET1390
- TUMS Thesis 1389 (Other Grant/Funding Number: TUMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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