Back to resultsThe Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Primary Purpose
Fever, Reduction in Temperature
Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Oral paracetamol
Intravenous paracetamol
Intramuscular diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Fever focused on measuring antipyretics, oral paracetamol, intravenous paracetamol, intramuscular diclofenac, emergency department
Eligibility Criteria
Inclusion Criteria:
- Adults between the age of 14-75 years with an oral temperature of more than 38.5 C
Exclusion Criteria:
- History of allergy to any of the drugs in the study
- Had taken antipyretics within 8 hours
- Renal, hepatic or haematological disorders
- bronchial asthma, peptic ulcer disease, vomiting
- Pregnant or lactating women
Sites / Locations
- Hamad medical corporation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
oral paracetamol
Intravenous paracetamol
Intramuscular Diclofenac
Arm Description
patients in this arm will receive 1000mg of oral paracetamol
patients in this arm will receive 1000 mg of intravenous paracetamol
patients in this arm will receive 75 mg of intramuscular diclofenac sodium
Outcomes
Primary Outcome Measures
Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics
Once the patients fulfill the inclusion criteria, they are randomly assigned to receive one of the three medications in the study ( oral paracetamol, intravenous paracetamol or intramuscular diclofenac). Baseline temperature is recorded using a standard thermometer. Then reduction in temperature is recorded every 30 minutes for 2 hours.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01891435
Brief Title
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Official Title
A Randomized Controlled Clinical Trial on the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever to Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
5. Study Description
Brief Summary
A randomized clinical trial to check the antipyretic efficacy of oral and intravenous paracetamol and intramuscular diclofenac sodium in patients presenting with fever to emergency department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Reduction in Temperature
Keywords
antipyretics, oral paracetamol, intravenous paracetamol, intramuscular diclofenac, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
434 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral paracetamol
Arm Type
Active Comparator
Arm Description
patients in this arm will receive 1000mg of oral paracetamol
Arm Title
Intravenous paracetamol
Arm Type
Active Comparator
Arm Description
patients in this arm will receive 1000 mg of intravenous paracetamol
Arm Title
Intramuscular Diclofenac
Arm Type
Active Comparator
Arm Description
patients in this arm will receive 75 mg of intramuscular diclofenac sodium
Intervention Type
Drug
Intervention Name(s)
Oral paracetamol
Intervention Description
after giving medicine temperature is checked every 30 minutes for 2 hours
Intervention Type
Drug
Intervention Name(s)
Intravenous paracetamol
Intervention Description
after giving medicine temperature is checked every 30 minutes for 2 hours
Intervention Type
Drug
Intervention Name(s)
Intramuscular diclofenac
Intervention Description
after giving medicine temperature is checked every 30 minutes for 2 hours
Primary Outcome Measure Information:
Title
Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics
Description
Once the patients fulfill the inclusion criteria, they are randomly assigned to receive one of the three medications in the study ( oral paracetamol, intravenous paracetamol or intramuscular diclofenac). Baseline temperature is recorded using a standard thermometer. Then reduction in temperature is recorded every 30 minutes for 2 hours.
Time Frame
Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults between the age of 14-75 years with an oral temperature of more than 38.5 C
Exclusion Criteria:
History of allergy to any of the drugs in the study
Had taken antipyretics within 8 hours
Renal, hepatic or haematological disorders
bronchial asthma, peptic ulcer disease, vomiting
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
osama H Mohammed
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad medical corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
12. IPD Sharing Statement
Learn more about this trial
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
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