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

Completed · Phase 3 · Has a placebo group

Conditions studied: Tonsillectomy

In brief

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

Key facts

Study ID

NCT01332253

Run by

Cumberland Pharmaceuticals

People needed

161

Starts

2011-07-01

Expected to finish

2012-08-01

Last updated by the study team

2016-11-03

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.

You may not qualify if…

• Have inadequate intravenous access
• Patients with significant cognitive impairment
• Active, clinically significant asthma
• History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-2 inhibitors, or fentanyl.
• Have a history of congenital bleeding diathesis (e.g. hemophilia) or any active clinically significant bleeding
• Any child with obstructive sleep apnea, defined as an Apnea-Hypopnea Index of greater than or equal to 5.0
• Have taken investigational drugs within 30 days before clinical trial material administration.
• 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.
• Refusal to provide written authorization for use and disclosure of protected health information.
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Where it is running

• Advanced ENT & Allergy — Louisville, Kentucky, United States
• University Hospital, University of Medicine and Dentistry NJ — Newark, New Jersey, United States
• Southeastern Clinical Research Associates — Charlotte, North Carolina, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Comprehensive Pain Specialists — Hendersonville, Tennessee, United States
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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