MedDataX Logo

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

NCT ID: NCT01332253

Last Updated: 2016-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tonsillectomy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tonsillectomy, Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous Ibuprofen

Group Type EXPERIMENTAL

Intravenous ibuprofen

Intervention Type DRUG

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

Normal Saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous ibuprofen

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

Intervention Type DRUG

Normal Saline

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Art P Wheeler, MD

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced ENT & Allergy

Louisville, Kentucky, United States

Site Status

University Hospital, University of Medicine and Dentistry NJ

Newark, New Jersey, United States

Site Status

Southeastern Clinical Research Associates

Charlotte, North Carolina, United States

Site Status

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Comprehensive Pain Specialists

Hendersonville, Tennessee, United States

Site Status

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CPI-CL-014

Identifier Type: -

Identifier Source: org_study_id