Trial Outcomes & Findings for Post-operative Pain Control After Pediatric Adenotonsillectomy (NCT NCT02296840)

Results Overview

Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

2 weeks after surgery

Results posted on

2018-04-25

Participant Flow

Participants were recruited between November 2014 and February 2016.

Eight of the 53 individuals who consented to taking part in the study did not meet eligibility criteria, resulting in 45 participants who began the intervention.

Participant milestones

Participant milestones
Measure	Ibuprofen Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Overall Study STARTED	18	27
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	9	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibuprofen Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	2	1
Overall Study Lost to Follow-up	6	17

Baseline Characteristics

Post-operative Pain Control After Pediatric Adenotonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen n=18 Participants Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen n=27 Participants Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	18 Participants n=93 Participants	27 Participants n=4 Participants	45 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	17 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment United States	18 Participants n=93 Participants	27 Participants n=4 Participants	45 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks after surgery

Population: Children who returned the completed the survey at two weeks post-surgery.

Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.

Outcome measures

Outcome measures
Measure	Ibuprofen n=10 Participants Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen n=8 Participants Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Faces Pain Score	158.95 units on a scale Standard Deviation 9.33	219.94 units on a scale Standard Deviation 21.43

SECONDARY outcome

Timeframe: 2 weeks after surgery

Population: All study participants are included in this analysis.

The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital).

Outcome measures

Outcome measures
Measure	Ibuprofen n=18 Participants Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen n=27 Participants Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Number of Participants With Post-operative Bleeding	2 Participants	0 Participants

Adverse Events

Ibuprofen

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Hydrocodone-acetaminophen

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ibuprofen n=18 participants at risk Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen n=27 participants at risk Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Metabolism and nutrition disorders Hospitalization due to low oral intake and dehydration	5.6% 1/18 • Number of events 1 • Adverse event data were collected for two weeks following surgery.	0.00% 0/27 • Adverse event data were collected for two weeks following surgery.

Other adverse events

Other adverse events
Measure	Ibuprofen n=18 participants at risk Participants randomized to receive ibuprofen (10mg/kg/day every 6-8 hours) after undergoing adenotonsillectomy.	Hydrocodone-acetaminophen n=27 participants at risk Participants randomized to receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours) after undergoing adenotonsillectomy.
Surgical and medical procedures Emergency room visit due to bleeding	5.6% 1/18 • Number of events 1 • Adverse event data were collected for two weeks following surgery.	0.00% 0/27 • Adverse event data were collected for two weeks following surgery.
Surgical and medical procedures Emergency room visit due to pain	0.00% 0/18 • Adverse event data were collected for two weeks following surgery.	3.7% 1/27 • Number of events 1 • Adverse event data were collected for two weeks following surgery.

Additional Information

Roy Rajan, MD

Emory University

Phone: 404-778-2400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place