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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 15, 2016
Last verified: September 2016
  Purpose
The hypothesis is 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:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. [ Time Frame: 30 minutes post-procedure ] [ Designated as safety issue: No ]
    The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.

  • Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. [ Time Frame: 60 minutes post-procedure ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.

  • Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure. [ Time Frame: 90 minutes post-procedure ] [ Designated as safety issue: No ]
    o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.

  • Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure. [ Time Frame: 120 minutes post-procedure ] [ Designated as safety issue: No ]
    To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain.

  • 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.

  • Time to Swallow Post Procedure. [ Time Frame: every 15 minutes until able to swallow ] [ Designated as safety issue: No ]
    Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.

  • Parent Satisfaction With Regards to Pain Management 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. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked "How satisfied were you with your child's pain management at the time of discharge?"

  • Parent Satisfaction With Regards to Nausea Management 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 nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked "How satisfied were you with your child's nausea management during the study?"

  • Parental Satisfaction With Vomiting Control in the Post-Operative Period. [ 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 vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked "How satisfied were you with your child's vomiting management during the study?"

  • Blood Loss During Surgery [ Time Frame: End of Surgery ] [ Designated as safety issue: Yes ]
    Amount of Blood Lost During Surgery in milliliters


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   (Child)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01332253     History of Changes
Other Study ID Numbers: CPI-CL-014 
Study First Received: April 7, 2011
Results First Received: May 10, 2016
Last Updated: September 15, 2016
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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016