Trial Outcomes & Findings for Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy (NCT NCT01244126)

Last Updated: 2016-03-03

Results Overview

FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

171 participants

Primary outcome timeframe

Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Results posted on

2016-03-03

Participant Flow

Children scheduled for bilateral myringotomy and insertion of tubes at TCH from September 2008 to Feb 2011

1531 children screened, 1143 excluded as not qualifying, 217 declined to participate

Participant milestones

Participant milestones
Measure	IM Morphine 0.1 mg/kg morphine IM	IV Morphine 0.1 mg/kg morphine IV	Fentanyl IN Intranasal fentanyl 2 mcg/kg IN
Overall Study STARTED	59	55	57
Overall Study COMPLETED	56	52	48
Overall Study NOT COMPLETED	3	3	9

Reasons for withdrawal

Reasons for withdrawal
Measure	IM Morphine 0.1 mg/kg morphine IM	IV Morphine 0.1 mg/kg morphine IV	Fentanyl IN Intranasal fentanyl 2 mcg/kg IN
Overall Study Protocol Violation	3	3	9

Baseline Characteristics

Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IM Morphine n=59 Participants 0.1 mg/kg morphine IM	IV Morphine n=55 Participants 0.1 mg/kg morphine IV	Fentanyl IN n=57 Participants Intranasal fentanyl 2 mcg/kg IN	Total n=171 Participants Total of all reporting groups
Age, Categorical <=18 years	59 Participants n=5 Participants	55 Participants n=7 Participants	57 Participants n=5 Participants	171 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	2.3 years STANDARD_DEVIATION 1.6 • n=5 Participants	2.7 years STANDARD_DEVIATION 2.2 • n=7 Participants	2.4 years STANDARD_DEVIATION 1.7 • n=5 Participants	2.4 years STANDARD_DEVIATION 1.8 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	24 Participants n=5 Participants	64 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	38 Participants n=7 Participants	33 Participants n=5 Participants	107 Participants n=4 Participants
Region of Enrollment United States	59 participants n=5 Participants	55 participants n=7 Participants	57 participants n=5 Participants	171 participants n=4 Participants
Weight in Kgs	14.1 Kgs STANDARD_DEVIATION 7.3 • n=5 Participants	15.2 Kgs STANDARD_DEVIATION 8.1 • n=7 Participants	13.3 Kgs STANDARD_DEVIATION 4.6 • n=5 Participants	14.2 Kgs STANDARD_DEVIATION 6.9 • n=4 Participants
Number completing study	56 participants n=5 Participants	52 participants n=7 Participants	48 participants n=5 Participants	156 participants n=4 Participants
Gender in patients completing study Male	35 Participants n=5 Participants	37 Participants n=7 Participants	29 Participants n=5 Participants	101 Participants n=4 Participants
Gender in patients completing study Female	21 Participants n=5 Participants	15 Participants n=7 Participants	19 Participants n=5 Participants	55 Participants n=4 Participants
ASA Physical Status in Patients who completed study ASA Physical Status 1	12 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	30 Participants n=4 Participants
ASA Physical Status in Patients who completed study ASA Physical Status 2	44 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants	126 Participants n=4 Participants

PRIMARY outcome

Timeframe: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Population: Analysis was performed on per protocol basis excluding patients with protocol violations

Outcome measures

Outcome measures
Measure	IM Morphine n=56 Participants 0.1 mg/kg morphine IM	IV Morphine n=52 Participants 0.1 mg/kg morphine IV	Fentanyl IN n=48 Participants Intranasal fentanyl 2 mcg/kg IN
Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.	2.9 units on a scale Standard Deviation 3.0	2.7 units on a scale Standard Deviation 3.2	2.0 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Population: The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data

Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium. 1\. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20.

Outcome measures

Outcome measures
Measure	IM Morphine n=56 Participants 0.1 mg/kg morphine IM	IV Morphine n=52 Participants 0.1 mg/kg morphine IV	Fentanyl IN n=48 Participants Intranasal fentanyl 2 mcg/kg IN
Maximum PAED Score	6.1 units on a scale Standard Deviation 6.2	6.3 units on a scale Standard Deviation 6.7	4.6 units on a scale Standard Deviation 5.8

Adverse Events

IM Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fentanyl IN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Helena Karlberg Hippard

Baylor College of Medicine, Department of Anesthesiology

Phone: 832-824-5800

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place