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Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

Information source: Cumberland Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tonsillectomy

Intervention: Intravenous ibuprofen (Drug); Normal Saline (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Cumberland Pharmaceuticals

Official(s) and/or principal investigator(s):
Art P Wheeler, MD, Study Director, Affiliation: Cumberland Pharmaceuticals Inc.

Summary

That a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.

Clinical Details

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Trial of the Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing the number of doses of fentanyl administered in the postoperative period prior to discharge.

Secondary outcome:

To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing postoperative pain as measured by the visual analog scale (VAS) in the post procedure period.

To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing time to discharge post procedure.

To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing time to swallow post procedure.

To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on improving parent satisfaction post procedure.

To determine the safety of intravenous ibuprofen compared to placebo for the treatment of pain by assessing treatment-emergent adverse events (AEs), and changes in blood loss during surgery as compared to patients receiving placebo.

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy. Exclusion Criteria: 1. Have inadequate intravenous access 2. Patients with significant cognitive impairment 3. Active, clinically significant asthma 4. History of allergy or hypersensitivity to any component of IVIb, NSAIDs, aspirin (or related products), COX-2 inhibitors, or fentanyl. 5. Have a history of congenital bleeding diathesis (e. g. hemophilia) or any active clinically significant bleeding 6. Any child with obstructive sleep apnea, defined as an AHI of greater than or equal to 5. 0 7. Have taken investigational drugs within 30 days before CTM administration. 8. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Surrogates will be needed for most patients. 9. Refusal to provide written authorization for use and disclosure of protected health information. 10. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Locations and Contacts

Advanced ENT & Allergy, Louisville, Kentucky 40207, United States

University Hospital, University of Medicine and Dentistry NJ, Newark, New Jersey 07101, United States

Southeastern Clinical Research Associates, Charlotte, North Carolina 28210, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States

Comprehensive Pain Specialists, Hendersonville, Tennessee 37075, United States

Baylor College of Medicine/Texas Children's Hospital, Houston, Texas 77030, United States

Additional Information

Starting date: July 2011
Last updated: February 3, 2014

Page last updated: August 23, 2015

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