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
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 |
That a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Cumberland Pharmaceuticals |
United States,
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 |
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