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

NCT04123717 | Completed Early Phase 1

• 1 other identifier: IRB 16206/16
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• Afebrile period/time to first fever recurrence

  6 hours

Other Outcomes (1)

• Febrile seizure occuring within 24 hours of study enrollment

  24 hours

Study Arms (4)

Arm1 - IV Ibuprofen

ACTIVE COMPARATOR

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

Arm 2 -IV Paracetamol

ACTIVE COMPARATOR

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

Arm 3- Both IV Paracetamol and IV Ibuprofen

ACTIVE COMPARATOR

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

Arm 4 -PO Brufen

ACTIVE COMPARATOR

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

Interventions

Intravenous Ibuprofen DRUG

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.

Also known as: Intravenous Acetaminophen, Intravenous Acetaminophen & Intravenous Brufen, Brufen PO

Arm 2 -IV Paracetamol; Arm 3- Both IV Paracetamol and IV Ibuprofen; Arm 4 -PO Brufen; Arm1 - IV Ibuprofen

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Have inadequate intravenous access
• Have received paracetamol within 4 hours and Ibuprofen within 6 hours before dosing
• 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.
• Have any history of allergy or hypersensitivity to NSAIDs, aspirin, Paracetamol, or any component of ibuprofen or .Paracetamol
• Known to have bleeding risk or diathesis such as hemophilia or thrombocytopenia
• Be receiving ongoing or imminent treatment with corticosteroids
• Be on dialysis, have oliguria, have impaired renal function or a renal transplant or known renal or hepatic disease
• Be otherwise unsuitable for the study, in the opinion of the Investigator.
• Any investigational drug use within 30 days prior to enrollment.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khalid Alansari

  Hamad Medical Corporation, Doha, Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Emergency Center's

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 11, 2019
• Study Start: October 11, 2019
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

QA (1)