NCT01332253

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

April 7, 2011

Results QC Date

May 10, 2016

Last Update Submit

September 15, 2016

Conditions

Tonsillectomy

Keywords

Tonsillectomy, Pediatric

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • 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) 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

  • Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.

    120 minutes post-procedure

  • Time to Discharge Post Procedure.

    Discharge

  • +5 more secondary outcomes

Study Arms (2)

Intravenous Ibuprofen

EXPERIMENTAL
Drug: Intravenous ibuprofen

Normal Saline

PLACEBO COMPARATOR
Other: Normal Saline

Interventions

Intravenous ibuprofenDRUG

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

Intravenous Ibuprofen
Normal SalineOTHER

Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Normal Saline

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

University Hospital, University of Medicine and Dentistry NJ

Newark, New Jersey, 07101, United States

Location

Southeastern Clinical Research Associates

Charlotte, North Carolina, 28210, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Comprehensive Pain Specialists

Hendersonville, Tennessee, 37075, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Byron Kaelin
Organization
Senior Manager, Clinical Operations
bkaelin@cumberlandpharma.com
615-255-0068

Study Officials

  • Art P Wheeler, MD

    Cumberland Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

November 3, 2016

Results First Posted

November 3, 2016

Record last verified: 2016-09

Locations

US(6)