Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy
- Registration Number
- NCT01332253
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- Patients between 6 and 17 years of age scheduled to undergo tonsillectomy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline Normal Saline - Intravenous Ibuprofen Intravenous ibuprofen -
- Primary Outcome Measures
Name Time Method Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. 4 hours 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
Name Time Method Time to Swallow Post Procedure. every 15 minutes until able to swallow 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. Discharge 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?"
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. 30 minutes post-procedure 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) 120 Minutes Post-procedure. 120 minutes post-procedure 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. Discharge To evaluate the secondary objective of pain, the time to participant discharge will be measured.
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. 60 minutes post-procedure 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. 90 minutes post-procedure 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.
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Discharge 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?"
Parent Satisfaction With Regards to Nausea Management Post Procedure. Discharge 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?"
Blood Loss During Surgery End of Surgery Amount of Blood Lost During Surgery in milliliters
Trial Locations
- Locations (6)
Southeastern Clinical Research Associates
🇺🇸Charlotte, North Carolina, 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, United States
Baylor College of Medicine/Texas Children's Hospital
🇺🇸Houston, Texas, United States
Comprehensive Pain Specialists
🇺🇸Hendersonville, Tennessee, United States