FeverNCT01891435
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
A study testing Oral paracetamol, Intravenous paracetamol and Intramuscular diclofenac in people with Fever and Reduction in Temperature, run by Hamad Medical Corporation at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Fever, Reduction in Temperature
- What is being tested?
- Oral paracetamol, Intravenous paracetamol and Intramuscular diclofenac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteQatar
- Study dates
- Jan 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults between the age of 14-75 years with an oral temperature of more than 38.5 C
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Fever, Reduction in Temperature
- Being tested
- Oral paracetamol, Intravenous paracetamol, Intramuscular diclofenac
- Keywords
- antipyretics, oral paracetamol, intravenous paracetamol, intramuscular diclofenac, emergency department
- Medical subject headings
- Fever, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral paracetamolDrug
after giving medicine temperature is checked every 30 minutes for 2 hours
Intravenous paracetamolDrug
after giving medicine temperature is checked every 30 minutes for 2 hours
Intramuscular diclofenacDrug
after giving medicine temperature is checked every 30 minutes for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| oral paracetamol | Active comparator | patients in this arm will receive 1000mg of oral paracetamol Receives: Drug: Oral paracetamol |
| Intravenous paracetamol | Active comparator | patients in this arm will receive 1000 mg of intravenous paracetamol Receives: Drug: Intravenous paracetamol |
| Intramuscular Diclofenac | Active comparator | patients in this arm will receive 75 mg of intramuscular diclofenac sodium Receives: Drug: Intramuscular diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Firjeeth C Paramba, Hamad Medical Corporation
- Investigators
- osama H Mohammed, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891435
- Sponsor's protocol ID
- 9070/09
- Status last verified
- Jun 2013
- First submitted
- 21 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01891435
- Acronym / sponsor ID
- 9070/09
- Conditions
- Fever, Reduction in Temperature
- Keywords
- antipyretics, oral paracetamol, intravenous paracetamol, intramuscular diclofenac, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral paracetamol | Active comparator | Drug: Oral paracetamolpatients in this arm will receive 1000mg of oral paracetamol |
| Intravenous paracetamol | Active comparator | Drug: Intravenous paracetamolpatients in this arm will receive 1000 mg of intravenous paracetamol |
| Intramuscular Diclofenac | Active comparator | Drug: Intramuscular diclofenacpatients in this arm will receive 75 mg of intramuscular diclofenac sodium |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults between the age of 14-75 years with an oral temperature of more than 38.5 C
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral paracetamolafter giving medicine temperature is checked every 30 minutes for 2 hours | Drug | oral paracetamol |
| Intravenous paracetamolafter giving medicine temperature is checked every 30 minutes for 2 hours | Drug | Intravenous paracetamol |
| Intramuscular diclofenacafter giving medicine temperature is checked every 30 minutes for 2 hours | Drug | Intramuscular Diclofenac |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osama H Mohammed principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral paracetamol, Intravenous paracetamol and Intramuscular diclofenac in people with Fever and Reduction in Temperature, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.