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

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Patrocinadors

Hamad Medical Corporation

ASSAIG CLÍNIC: NCT04123717

BioSeek: nct04123717

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Resum

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.

Descripció

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.

Dates

Darrera verificació:	09/30/2019
Primer enviat:	10/06/2019
Inscripció estimada enviada:	10/09/2019
Publicat per primera vegada:	10/10/2019
Última actualització enviada:	10/13/2019
Publicació de l'última actualització:	10/14/2019
Data d'inici de l'estudi real:	10/10/2019
Data estimada de finalització primària:	12/30/2020
Data estimada de finalització de l’estudi:	01/31/2021

Condició o malaltia

Fever

Intervenció / tractament

Drug: Intravenous Ibuprofen

Fase

Grups de braços

Braç	Intervenció / tractament
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.
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.
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
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.

Criteris d'elegibilitat

Edats elegibles per estudiar	6 Months Per a 6 Months
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	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.

Resultat

Mesures de resultats primaris

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 [4 hours]

Area under the curve for fever will be calculated as the difference between measured temperature at a given time and 38°C.

Mesures de resultats secundaris

1. Afebrile period/time to first fever recurrence [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.

Altres mesures de resultats

1. Febrile seizure occuring within 24 hours of study enrollment [24 hours]

Safety and tolerability of IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, and PO ibuprofen based on Adverse Events