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

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

Official Title
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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

Conditions
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Tonsillectomy

Intervention / Treatment
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* Drug: Intravenous ibuprofen
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Ibuprofen<br> | Drug: Intravenous ibuprofen<br>* Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.<br>|
| Placebo Comparator: Normal Saline<br> | Other: Normal Saline<br>* Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain as Measured by the Visual Analog Scale (VAS) 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. | 30 minutes post-procedure | 
| Postoperative Pain as Measured by the Visual Analog Scale (VAS) 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. | 60 minutes post-procedure | 
| Postoperative Pain as Measured by the Visual Analog Scale (VAS) 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. | 90 minutes post-procedure | 
| Postoperative Pain as Measured by the Visual Analog Scale (VAS) 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. | 120 minutes post-procedure | 
| Time to Discharge Post Procedure. | To evaluate the secondary objective of pain, the time to participant discharge will be measured. | Discharge | 
| Time to Swallow Post Procedure. | Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded. | every 15 minutes until able to swallow | 
| Parent Satisfaction With Regards to Pain Management Post Procedure. | 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? | Discharge | 
| Parent Satisfaction With Regards to Nausea Management Post Procedure. | 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? | Discharge | 
| Parental Satisfaction With Vomiting Control in the Post-Operative Period. | 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? | Discharge | 
| Blood Loss During Surgery | Amount of Blood Lost During Surgery in milliliters | End of Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Pediatric