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

Cumberland Pharmaceuticals6 sites in 1 country161 target enrollmentJuly 2011

ConditionsTonsillectomy

InterventionsIntravenous ibuprofen Normal Saline

DrugsIntravenous ibuprofen

Overview

Phase: Phase 3
Intervention: Intravenous ibuprofen
Conditions: Tonsillectomy
Sponsor: Cumberland Pharmaceuticals
Enrollment: 161
Locations: 6
Primary Endpoint: Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

August 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cumberland Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.

Arms & Interventions

Intravenous Ibuprofen

Intervention: Intravenous ibuprofen

Normal Saline

Intervention: Normal Saline

Outcomes

Primary Outcomes

Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.

Time Frame: 4 hours

To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.

Secondary Outcomes

Time to Swallow Post Procedure.(every 15 minutes until able to swallow)
Parent Satisfaction With Regards to Pain Management Post Procedure.(Discharge)
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.(30 minutes post-procedure)
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.(120 minutes post-procedure)
Time to Discharge Post Procedure.(Discharge)
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.(60 minutes post-procedure)
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.(90 minutes post-procedure)
Parental Satisfaction With Vomiting Control in the Post-Operative Period.(Discharge)
Parent Satisfaction With Regards to Nausea Management Post Procedure.(Discharge)
Blood Loss During Surgery(End of Surgery)