The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
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
1 other identifier
interventional
434
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedJuly 3, 2013
June 1, 2013
1.9 years
June 21, 2013
June 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes
Study Arms (3)
oral paracetamol
ACTIVE COMPARATORpatients in this arm will receive 1000mg of oral paracetamol
Intravenous paracetamol
ACTIVE COMPARATORpatients in this arm will receive 1000 mg of intravenous paracetamol
Intramuscular Diclofenac
ACTIVE COMPARATORpatients in this arm will receive 75 mg of intramuscular diclofenac sodium
Interventions
after giving medicine temperature is checked every 30 minutes for 2 hours
after giving medicine temperature is checked every 30 minutes for 2 hours
after giving medicine temperature is checked every 30 minutes for 2 hours
Eligibility Criteria
You may qualify if:
- Adults between the age of 14-75 years with an oral temperature of more than 38.5 C
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hamad medical corporation
Doha, 3050, Qatar
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
osama H Mohammed
Hamad Medical Corporation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, Emergency Department
Study Record Dates
First Submitted
June 21, 2013
First Posted
July 3, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
April 1, 2013
Last Updated
July 3, 2013
Record last verified: 2013-06