Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever

August 13, 2024 updated by: DR. KHALID AL-ANSARI, Hamad Medical Corporation

Fever is one of the most common reasons children are brought to emergency departments. Treatment of fever with antipyretics is usually done simply to make children more comfortable, although in some circumstances, such as febrile seizure, control of fever is critically important.

The investigators seek to compare the two most widely-used IV antipyretic medications, paracetamol and ibuprofen, in multiple measures of fever control. Although there is much data evaluating adults fever, as well as these medications for analgesia in both children and adults, there is scant published data on the topic: One IV Ibuprofen study of 100 children, and one study of IV paracetamol with 67 children.1,6 Due to the highly limited published data evaluating IV ibuprofen and IV paracetamol for pediatric fever due to infection, the investigators seek to conduct a pilot study in order to know the effect size and accurately estimate a sample size in order to design a full randomized controlled trail.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upon arrival, when patients are found to be febrile, the parent and patient are informed by the treating physician about their study eligibility. They are provided with study information and a consent form, and given the opportunity to discuss the study with a research nurse or assistant.

Within 10 minutes a decision to consent for the study must be made, and if no consent is made the patient is excluded from the study.

After consent into the study, study subjects will be randomized to arm 1,2,3 or 4.

Study Medications: Arm 1,2,3,4:

Will have an intravenous catheter placed by standard method practiced in the Al Saad Pediatric Emergency Center. All febrile patients admitted in the facility have an intravenous catheter placed as a standard practice, so they will not require an IV catheter simply for the purpose of delivering study medications. This will typically be a 24 gauge or 22 gauge angiocatheter, secured with tegaderm and tape. After placement of this IV catheter, the patient will receive the study medication(s).The dosing of these medications, specifically ibuprofen 10 mg/kg and paracetamol 15 mg/kg is standard dosing routinely used in pediatrics.

Arm 1- Patients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 mL normal saline.

Arm 2- Patients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline.

Arm 3- Patients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen as described above. Their IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol as described above.

Arm 4- Patients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered.

.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 6 months to 14 years.
  2. Fever ≥ 38.3°C
  3. Admitted to observation unit of Al Saad Pediatric Emergency Center

Exclusion Criteria:

  1. Have inadequate intravenous access
  2. Have received paracetamol within 4 hours and Ibuprofen within 6 hours before dosing
  3. Have fever that is chronic or not new in onset in the preceding 7 days; such as fever from rheumatologic conditions, cancer, or fever of unknown origin, and any fever as a result of transfusion of blood products.
  4. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, Paracetamol, or any component of ibuprofen or .Paracetamol
  5. Known to have bleeding risk or diathesis such as hemophilia or thrombocytopenia
  6. Be receiving ongoing or imminent treatment with corticosteroids
  7. Be on dialysis, have oliguria, have impaired renal function or a renal transplant or known renal or hepatic disease
  8. Be otherwise unsuitable for the study, in the opinion of the Investigator.
  9. Any investigational drug use within 30 days prior to enrollment.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm1 - IV Ibuprofen
Patients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 ml normal saline.
Drug: Intravenous Ibuprofen
The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
Other Names:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO
Active Comparator: Arm 2 -IV Paracetamol
Patients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline.
Drug: Intravenous Ibuprofen
The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
Other Names:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO
Active Comparator: Arm 3- Both IV Paracetamol and IV Ibuprofen
Patients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen and the IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol
Drug: Intravenous Ibuprofen
The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
Other Names:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO
Active Comparator: Arm 4 -PO Brufen
Patients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered.
Drug: Intravenous Ibuprofen
The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
Other Names:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint will be the Area under the curve for fever in the 4 hours after administration of each study arm relative to Area under the curve for fever of Ibuprofen
Time Frame: 4 hours
Area under the curve for fever will be calculated as the difference between measured temperature at a given time and 38°C.
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Afebrile period/time to first fever recurrence
Time Frame: 6 hours
Afebrile period as calculated to be the time from first temperature measurement less than 38°C occurring after fever until the first temperature greater than or equal to 38.3°C occurring after fever.
6 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Febrile seizure occuring within 24 hours of study enrollment
Time Frame: 24 hours
Safety and tolerability of IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, and PO ibuprofen based on Adverse Events
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamad Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khalid Alansari, Hamad Medical Corporation, Doha, Qatar

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 16206/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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