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

Tonsillectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332253
• Other study ID #: CPI-CL-014
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: February 3, 2014
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Drug:
• Intravenous ibuprofen
Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.

Other:
• Normal Saline
Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	4 hours	No
Secondary	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 secondary objective of pain, patient reported pain post-procedure using a VAS scale will be measured.	post-dose	No
Secondary	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 secondary objective of pain, the time to participant discharge will be measured.	Discharge	No
Secondary	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 secondary objective of pain, the time to participant first swallow will be measured.	4 hours	No
Secondary	To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on improving parent satisfaction post procedure.	To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management.	Discharge	No
Secondary	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.		48 hours after discharge	Yes