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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01332253
First received: April 7, 2011
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Tonsillectomy
 Drug: Intravenous ibuprofen
Other: Normal Saline
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. [ Time Frame: post-dose ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, patient reported pain post-procedure using a VAS scale will be measured.

  • To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing time to discharge post procedure. [ Time Frame: Discharge ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, the time to participant discharge will be measured.

  • To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on reducing time to swallow post procedure. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, the time to participant first swallow will be measured.

  • To evaluate the efficacy of intravenous ibuprofen compared to placebo when administered as a single preemptive dose, on improving parent satisfaction post procedure. [ Time Frame: Discharge ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management.

  • 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. [ Time Frame: 48 hours after discharge ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: July 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous Ibuprofen Drug: Intravenous ibuprofen
Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
Placebo Comparator: Normal Saline Other: Normal Saline
Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332253

Locations
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, New Jersey
University Hospital, University of Medicine and Dentistry NJ
Newark, New Jersey, United States, 07101
United States, North Carolina
Southeastern Clinical Research Associates
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Comprehensive Pain Specialists
Hendersonville, Tennessee, United States, 37075
United States, Texas
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art P Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01332253     History of Changes
Other Study ID Numbers: CPI-CL-014
Study First Received: April 7, 2011
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Tonsillectomy, Pediatric

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013