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

June 28, 2013 updated by: Firjeeth C Paramba, Hamad Medical Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

434

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Hamad Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral paracetamol
patients in this arm will receive 1000mg of oral paracetamol
Drug: Oral paracetamol
after giving medicine temperature is checked every 30 minutes for 2 hours
Active Comparator: Intravenous paracetamol
patients in this arm will receive 1000 mg of intravenous paracetamol
Drug: Intravenous paracetamol
after giving medicine temperature is checked every 30 minutes for 2 hours
Active Comparator: Intramuscular Diclofenac
patients in this arm will receive 75 mg of intramuscular diclofenac sodium
Drug: Intramuscular diclofenac
after giving medicine temperature is checked every 30 minutes for 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics
Time Frame: Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: osama H Mohammed, Hamad Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9070/09

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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