Trial Outcomes & Findings for Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy (NCT NCT01244126)
NCT ID: 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)
COMPLETED
PHASE4
171 participants
Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge
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
| 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
| 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
| 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=99 Participants
|
55 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
171 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Continuous
|
2.3 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
2.7 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
2.4 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
2.4 years
STANDARD_DEVIATION 1.8 • n=157 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
64 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
107 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=99 Participants
|
55 participants
n=107 Participants
|
57 participants
n=206 Participants
|
171 participants
n=157 Participants
|
|
Weight in Kgs
|
14.1 Kgs
STANDARD_DEVIATION 7.3 • n=99 Participants
|
15.2 Kgs
STANDARD_DEVIATION 8.1 • n=107 Participants
|
13.3 Kgs
STANDARD_DEVIATION 4.6 • n=206 Participants
|
14.2 Kgs
STANDARD_DEVIATION 6.9 • n=157 Participants
|
|
Number completing study
|
56 participants
n=99 Participants
|
52 participants
n=107 Participants
|
48 participants
n=206 Participants
|
156 participants
n=157 Participants
|
|
Gender in patients completing study
Male
|
35 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
101 Participants
n=157 Participants
|
|
Gender in patients completing study
Female
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
55 Participants
n=157 Participants
|
|
ASA Physical Status in Patients who completed study
ASA Physical Status 1
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
30 Participants
n=157 Participants
|
|
ASA Physical Status in Patients who completed study
ASA Physical Status 2
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
126 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at dischargePopulation: Analysis was performed on per protocol basis excluding patients with protocol violations
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)
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 dischargePopulation: 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
| 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
Fentanyl IN
IV Morphine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place