Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Paracetamol, Morphine sulfates, Acute pain
Eligibility Criteria
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
Sites / Locations
- TUMS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IV Paracetamol
IV Morphine Sulfate
Arm Description
Outcomes
Primary Outcome Measures
Change in pain severity/score
Secondary Outcome Measures
Need for rescue analgesia
Full Information
NCT ID
NCT01465984
First Posted
November 2, 2011
Last Updated
December 6, 2012
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01465984
Brief Title
Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
Official Title
Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Paracetamol, Morphine sulfates, Acute pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV Paracetamol
Arm Type
Experimental
Arm Title
IV Morphine Sulfate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
Primary Outcome Measure Information:
Title
Change in pain severity/score
Time Frame
after 30 minutes
Secondary Outcome Measure Information:
Title
Need for rescue analgesia
Time Frame
After 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Organizational Affiliation
TUMS
Official's Role
Study Director
Facility Information:
Facility Name
TUMS
City
Tehran
ZIP/Postal Code
1417613151
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
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