Clinical trial NCT01332253: Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tonsillectomy
Keywords: Tonsillectomy, Pediatric
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 161
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 intravenous ibuprofen, NSAIDs, aspirin (or related products), cyclooxygenase-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 Apnea-Hypopnea Index of greater than or equal to 5.0
7. Have taken investigational drugs within 30 days before clinical trial material 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.

Primary outcomes:
measure: Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.
timeFrame: 4 hours
Secondary outcomes:
measure: Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.
timeFrame: 30 minutes post-procedure
measure: Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.
timeFrame: 60 minutes post-procedure
measure: Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.
timeFrame: 90 minutes post-procedure
measure: Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.
timeFrame: 120 minutes post-procedure
measure: Time to Discharge Post Procedure.
timeFrame: Discharge
measure: Time to Swallow Post Procedure.
timeFrame: every 15 minutes until able to swallow
measure: Parent Satisfaction With Regards to Pain Management Post Procedure.
timeFrame: Discharge
measure: Parent Satisfaction With Regards to Nausea Management Post Procedure.
timeFrame: Discharge
measure: Parental Satisfaction With Vomiting Control in the Post-Operative Period.
timeFrame: Discharge
measure: Blood Loss During Surgery
timeFrame: End of Surgery
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Newark
country: United States
facility: University Hospital, University of Medicine and Dentistry NJ
state: New Jersey
city: Charlotte
country: United States
facility: Southeastern Clinical Research Associates
state: North Carolina
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art P Wheeler, MD
role: STUDY_DIRECTOR
References: