Skip to main content
OpenTrials
Completed

NCT Number: NCT01332253

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advanced ENT & Allergy, Louisville, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Intravenous Ibuprofen

Drug

Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.

Normal Saline

Other

Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Primary outcomes

  1. Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.

    Time frame: 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 outcomes

  1. Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.

    Time frame: 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.

  2. Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.

    Time frame: 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.

  3. Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.

    Time frame: 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.

  4. Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.

    Time frame: 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.

  5. Time to Discharge Post Procedure.

    Time frame: Discharge

    To evaluate the secondary objective of pain, the time to participant discharge will be measured.

  6. Time to Swallow Post Procedure.

    Time frame: 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.

  7. Parent Satisfaction With Regards to Pain Management Post Procedure.

    Time frame: 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?"

  8. Parent Satisfaction With Regards to Nausea Management Post Procedure.

    Time frame: 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?"

  9. Parental Satisfaction With Vomiting Control in the Post-Operative Period.

    Time frame: 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?"

  10. Blood Loss During Surgery

    Time frame: End of Surgery

    Amount of Blood Lost During Surgery in milliliters

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2011
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.