Trial Outcomes & Findings for Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy (NCT NCT01332253)

NCT ID: NCT01332253

Last Updated: 2016-11-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 161 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2016-11-03

Participant Flow

Participant milestones

Measure	Intravenous Ibuprofen Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Overall Study STARTED	82	79
Overall Study COMPLETED	82	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.	Total n=161 Participants Total of all reporting groups
Age, Continuous	10 years STANDARD_DEVIATION 3.4 • n=5 Participants	9 years STANDARD_DEVIATION 3.0 • n=7 Participants	9 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	79 participants n=7 Participants	161 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.	1.5 fentanyl doses Standard Deviation 1.32	1.7 fentanyl doses Standard Deviation 1.12

SECONDARY outcome

Timeframe: 30 minutes post-procedure

Population: Patient reported pain was evaluated utilizing a 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.	51 millimeters Standard Deviation 30.9	55 millimeters Standard Deviation 27.4

SECONDARY outcome

Timeframe: 60 minutes post-procedure

Population: Patient reported pain was evaluated utilizing a 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.	39 millimeters Standard Deviation 27.4	47 millimeters Standard Deviation 30.8

SECONDARY outcome

Timeframe: 90 minutes post-procedure

Population: Patient reported pain was evaluated utilizing a 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.	29 millimeters Standard Deviation 29.3	35 millimeters Standard Deviation 30.8

SECONDARY outcome

Timeframe: 120 minutes post-procedure

Population: Patient reported pain was evaluated utilizing a 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.	22 millimeters Standard Deviation 26.2	27 millimeters Standard Deviation 29.3

SECONDARY outcome

Timeframe: Discharge

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

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Time to Discharge Post Procedure.	1.9 hours Standard Error 0.10	1.9 hours Standard Error 0.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Time to Swallow Post Procedure.	0.5 hours Standard Error 0.04	0.4 hours Standard Error 0.03

SECONDARY outcome

Timeframe: Discharge

Population: Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of 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?"

Outcome measures

Measure	Intravenous Ibuprofen n=73 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=65 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Parent Satisfaction With Regards to Pain Management Post Procedure. Strongly Agree	58 participants	58 participants
Parent Satisfaction With Regards to Pain Management Post Procedure. Agree	11 participants	6 participants
Parent Satisfaction With Regards to Pain Management Post Procedure. Neutral	1 participants	1 participants
Parent Satisfaction With Regards to Pain Management Post Procedure. Disagree	2 participants	0 participants
Parent Satisfaction With Regards to Pain Management Post Procedure. Strongly Disagree	0 participants	0 participants
Parent Satisfaction With Regards to Pain Management Post Procedure. Survey question not completed	1 participants	0 participants

SECONDARY outcome

Timeframe: Discharge

Population: Summary of Satisfaction Post-Procedure with nausea management during the study

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?"

Outcome measures

Measure	Intravenous Ibuprofen n=73 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=65 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Parent Satisfaction With Regards to Nausea Management Post Procedure. Strongly Agree	64 participants	57 participants
Parent Satisfaction With Regards to Nausea Management Post Procedure. Agree	7 participants	5 participants
Parent Satisfaction With Regards to Nausea Management Post Procedure. Neutral	0 participants	2 participants
Parent Satisfaction With Regards to Nausea Management Post Procedure. Disagree	0 participants	0 participants
Parent Satisfaction With Regards to Nausea Management Post Procedure. Strongly Disagree	0 participants	0 participants
Parent Satisfaction With Regards to Nausea Management Post Procedure. Survey question not completed	2 participants	1 participants

SECONDARY outcome

Timeframe: Discharge

Population: Summary of Satisfaction Post-Procedure with Vomiting Control.

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?"

Outcome measures

Measure	Intravenous Ibuprofen n=73 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=65 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Strongly Agree	66 participants	59 participants
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Agree	3 participants	4 participants
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Neutral	1 participants	2 participants
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Disagree	0 participants	0 participants
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Strongly Disagree	0 participants	0 participants
Parental Satisfaction With Vomiting Control in the Post-Operative Period. Survey question not completed	3 participants	0 participants

SECONDARY outcome

Timeframe: End of Surgery

Population: Blood loss during surgery in milliliters

Amount of Blood Lost During Surgery in milliliters

Outcome measures

Measure	Intravenous Ibuprofen n=82 Participants Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 Participants Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Blood Loss During Surgery	15 milliliters Standard Deviation 29.6	16 milliliters Standard Deviation 39.3

Adverse Events

Intravenous Ibuprofen

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Ibuprofen n=82 participants at risk Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 participants at risk Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Respiratory, thoracic and mediastinal disorders Tonsillar haemorrhage	1.2% 1/82 • Number of events 1	0.00% 0/79

Other adverse events

Measure	Intravenous Ibuprofen n=82 participants at risk Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.	Normal Saline n=79 participants at risk Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
Gastrointestinal disorders Vomiting	3.7% 3/82 • Number of events 3	2.5% 2/79 • Number of events 2
Nervous system disorders Agitation	1.2% 1/82 • Number of events 1	3.8% 3/79 • Number of events 3
Nervous system disorders Restlessness	0.00% 0/82	2.5% 2/79 • Number of events 2
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/82	2.5% 2/79 • Number of events 2
Injury, poisoning and procedural complications Infusion Site Pain	3.7% 3/82 • Number of events 3	0.00% 0/79
Immune system disorders Bronchospasm	0.00% 0/82	2.5% 2/79 • Number of events 2

Additional Information

Byron Kaelin

Senior Manager, Clinical Operations

Phone: 615-255-0068

Email: bkaelin@cumberlandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place