Tonsillectomy
Conditions
Keywords
Tonsillectomy, Pediatric
Brief summary
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.
Interventions
Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
OTHERNormal Saline
Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) 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. |
| 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? |
| 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? |
| 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? |
| Blood Loss During Surgery | End of Surgery | Amount of Blood Lost During Surgery in milliliters |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Ibuprofen Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. | 82 |
| Normal Saline Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. | 79 |
| Total | 161 |
Baseline characteristics
| Characteristic | Intravenous Ibuprofen | Total | Normal Saline |
|---|---|---|---|
| Age, Continuous | 10 years STANDARD_DEVIATION 3.4 | 9 years STANDARD_DEVIATION 3.2 | 9 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 134 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 137 Participants | 68 Participants |
| Region of Enrollment United States | 82 participants | 161 participants | 79 participants |
| Sex: Female, Male Female | 31 Participants | 62 Participants | 31 Participants |
| Sex: Female, Male Male | 51 Participants | 99 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 82 | 10 / 79 |
| serious Total, serious adverse events | 1 / 82 | 0 / 79 |
Outcome results
Primary
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.
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. | 1.5 fentanyl doses | Standard Deviation 1.32 |
| Normal Saline | Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge. | 1.7 fentanyl doses | Standard Deviation 1.12 |
Secondary
Blood Loss During Surgery
Amount of Blood Lost During Surgery in milliliters
Time frame: End of Surgery
Population: Blood loss during surgery in milliliters
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Blood Loss During Surgery | 15 milliliters | Standard Deviation 29.6 |
| Normal Saline | Blood Loss During Surgery | 16 milliliters | Standard Deviation 39.3 |
Secondary
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?
Time frame: Discharge
Population: Summary of Satisfaction Post-Procedure with Vomiting Control.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Strongly Agree | 66 participants |
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Agree | 3 participants |
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Neutral | 1 participants |
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Disagree | 0 participants |
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Strongly Disagree | 0 participants |
| Intravenous Ibuprofen | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Survey question not completed | 3 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Strongly Disagree | 0 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Strongly Agree | 59 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Disagree | 0 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Agree | 4 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Survey question not completed | 0 participants |
| Normal Saline | Parental Satisfaction With Vomiting Control in the Post-Operative Period. | Neutral | 2 participants |
Secondary
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?
Time frame: Discharge
Population: Summary of Satisfaction Post-Procedure with nausea management during the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Strongly Agree | 64 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Agree | 7 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Neutral | 0 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Disagree | 0 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Strongly Disagree | 0 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Survey question not completed | 2 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Strongly Disagree | 0 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Strongly Agree | 57 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Disagree | 0 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Agree | 5 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Survey question not completed | 1 participants |
| Normal Saline | Parent Satisfaction With Regards to Nausea Management Post Procedure. | Neutral | 2 participants |
Secondary
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?
Time frame: Discharge
Population: Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge?
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Survey question not completed | 1 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Agree | 11 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Strongly Disagree | 0 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Neutral | 1 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Strongly Agree | 58 participants |
| Intravenous Ibuprofen | Parent Satisfaction With Regards to Pain Management Post Procedure. | Disagree | 2 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Strongly Agree | 58 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Strongly Disagree | 0 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Survey question not completed | 0 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Disagree | 0 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Agree | 6 participants |
| Normal Saline | Parent Satisfaction With Regards to Pain Management Post Procedure. | Neutral | 1 participants |
Secondary
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.
Time frame: 120 minutes post-procedure
Population: Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure. | 22 millimeters | Standard Deviation 26.2 |
| Normal Saline | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure. | 27 millimeters | Standard Deviation 29.3 |
Secondary
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.
Time frame: 30 minutes post-procedure
Population: Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. | 51 millimeters | Standard Deviation 30.9 |
| Normal Saline | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure. | 55 millimeters | Standard Deviation 27.4 |
Secondary
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.
Time frame: 60 minutes post-procedure
Population: Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. | 39 millimeters | Standard Deviation 27.4 |
| Normal Saline | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure. | 47 millimeters | Standard Deviation 30.8 |
Secondary
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.
Time frame: 90 minutes post-procedure
Population: Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure. | 29 millimeters | Standard Deviation 29.3 |
| Normal Saline | Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure. | 35 millimeters | Standard Deviation 30.8 |
Secondary
Time to Discharge Post Procedure.
To evaluate the secondary objective of pain, the time to participant discharge will be measured.
Time frame: Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Time to Discharge Post Procedure. | 1.9 hours | Standard Error 0.1 |
| Normal Saline | Time to Discharge Post Procedure. | 1.9 hours | Standard Error 0.11 |
Secondary
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.
Time frame: every 15 minutes until able to swallow
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Ibuprofen | Time to Swallow Post Procedure. | 0.5 hours | Standard Error 0.04 |
| Normal Saline | Time to Swallow Post Procedure. | 0.4 hours | Standard Error 0.03 |