Clinical Trials Logo
  1. Home
  2. Fever
  3. NCT01002573

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Fever Clinical Trial

Official title:
A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Clinical Trial Summary

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Clinical Trial Description

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01002573
Study type Interventional
Source Cumberland Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date July 2010
Completion date June 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03706599 - Fever Infants and Therapeutic Education in Emergency Department N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT01782183 - Thermographic Characteristics of Sore Throat by Thermographic Camera N/A
Withdrawn NCT00800696 - Preventive Oral Care N/A
Completed NCT02212990 - The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine N/A
Completed NCT02689193 - IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Completed NCT01869699 - Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults Phase 4
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Completed NCT01194557 - Introducing Rapid Diagnostic Tests Into the Private Health Sector N/A
Completed NCT00940654 - The Fever and Antipyretic in Critically Illness Evaluation Study N/A
Completed NCT00969176 - Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates Phase 2/Phase 3
Recruiting NCT00729976 - Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study. Phase 4
Recruiting NCT00389272 - Adding a Second Drug for Febrile Children Treated With Acetaminophen N/A
Completed NCT00257790 - The Tobramycin Study Phase 4
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Completed NCT02595827 - Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo Phase 3
Recruiting NCT06061575 - Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients Phase 4
Recruiting NCT06038617 - Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children Phase 4