The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891435
• Other study ID #: 9070/09
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: June 28, 2013
• Start date: January 2010
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar: Hamad Medical Corporation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: April 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Reduction in Temperature

Intervention

Drug:
• Oral paracetamol
after giving medicine temperature is checked every 30 minutes for 2 hours
• Intravenous paracetamol
after giving medicine temperature is checked every 30 minutes for 2 hours
• Intramuscular diclofenac
after giving medicine temperature is checked every 30 minutes for 2 hours

Locations

Country	Name	City	State
Qatar	Hamad medical corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes