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Trial record 42 of 834 for:    Texas Children's Hospital | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT01244126
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Helena Karlberg, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Otitis Media
Interventions Drug: Intranasal fentanyl
Drug: morphine IM
Drug: IV morphine
Enrollment 171
Recruitment Details Children scheduled for bilateral myringotomy and insertion of tubes at TCH from September 2008 to Feb 2011
Pre-assignment Details 1531 children screened, 1143 excluded as not qualifying, 217 declined to participate
Arm/Group Title IM Morphine IV Morphine Fentanyl IN
Hide Arm/Group Description 0.1 mg/kg morphine IM 0.1 mg/kg morphine IV Intranasal fentanyl 2 mcg/kg IN
Period Title: Overall Study
Started 59 55 57
Completed 56 52 48
Not Completed 3 3 9
Reason Not Completed
Protocol Violation             3             3             9
Arm/Group Title IM Morphine IV Morphine Fentanyl IN Total
Hide Arm/Group Description 0.1 mg/kg morphine IM 0.1 mg/kg morphine IV Intranasal fentanyl 2 mcg/kg IN Total of all reporting groups
Overall Number of Baseline Participants 59 55 57 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 57 participants 171 participants
<=18 years
59
 100.0%
55
 100.0%
57
 100.0%
171
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 55 participants 57 participants 171 participants
2.3  (1.6) 2.7  (2.2) 2.4  (1.7) 2.4  (1.8)
[1]
Measure Description: Limited to patients who completed study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 57 participants 171 participants
Female
23
  39.0%
17
  30.9%
24
  42.1%
64
  37.4%
Male
36
  61.0%
38
  69.1%
33
  57.9%
107
  62.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 55 participants 57 participants 171 participants
59 55 57 171
Weight in Kgs   [1] 
Mean (Standard Deviation)
Unit of measure:  Kgs
Number Analyzed 59 participants 55 participants 57 participants 171 participants
14.1  (7.3) 15.2  (8.1) 13.3  (4.6) 14.2  (6.9)
[1]
Measure Description: Excluded 15 patients for protocol violations. These 15 patients did not undergo study procedures Baseline measures only of completed cases
Number completing study   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 57 participants 171 participants
56 52 48 156
[1]
Measure Description: 15 cases excluded for protocol violations including 3, 3 and 9 in the IM morphine, IV morphine and IN fentanyl groups respectively.
Gender in patients completing study   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 57 participants 171 participants
Male 35 37 29 101
Female 21 15 19 55
[1]
Measure Description: Excluding protocol violations
ASA Physical Status in Patients who completed study   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 55 participants 57 participants 171 participants
ASA Physical Status 1 12 11 7 30
ASA Physical Status 2 44 41 41 126
[1]
Measure Description:

Limited to those who completed study and excluding protocol violations

ASA PHYSICAL STATUS CLASSIFICATION SYSTEM Last approved by the ASA House of Delegates on October 15, 2014 Definition ASA I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use ASA II A patient with mild systemic disease Mild diseases only without substantive functional limitations.

1.Primary Outcome
Title Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.
Hide Description 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)
Time Frame Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per protocol basis excluding patients with protocol violations
Arm/Group Title IM Morphine IV Morphine Fentanyl IN
Hide Arm/Group Description:
0.1 mg/kg morphine IM
0.1 mg/kg morphine IV
Intranasal fentanyl 2 mcg/kg IN
Overall Number of Participants Analyzed 56 52 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (3.0) 2.7  (3.2) 2.0  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Morphine, IV Morphine, Fentanyl IN
Comments The primary outcome of the study was the maximum postoperative FLACC pain score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter Kruskall Wallis ANOVA by ranks
Estimated Value 0.21
Parameter Dispersion
Type: Standard Deviation
Value: 3.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Maximum PAED Score
Hide Description

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.

Time Frame Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title IM Morphine IV Morphine Fentanyl IN
Hide Arm/Group Description:
0.1 mg/kg morphine IM
0.1 mg/kg morphine IV
Intranasal fentanyl 2 mcg/kg IN
Overall Number of Participants Analyzed 56 52 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.1  (6.2) 6.3  (6.7) 4.6  (5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Morphine, IV Morphine, Fentanyl IN
Comments Kruskall Wallis test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Method of Estimation Estimation Parameter Kruskall Wallis ANOVA
Estimated Value 0.34
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IM Morphine Fentanyl IN IV Morphine
Hide Arm/Group Description 0.1 mg/kg morphine IM Intranasal fentanyl 2 mcg/kg IN 0.1 mg/kg morphine IV
All-Cause Mortality
IM Morphine Fentanyl IN IV Morphine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IM Morphine Fentanyl IN IV Morphine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/53 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IM Morphine Fentanyl IN IV Morphine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/53 (0.00%)   0/53 (0.00%) 
This study used an objective pain scale where the minimum clinically important difference in scores is unknown. The study did not use a group receiving no active treatment as this was unethical. We also did not measure blood levels of opioids.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Helena Karlberg Hippard
Organization: Baylor College of Medicine, Department of Anesthesiology
Phone: 832-824-5800
Responsible Party: Helena Karlberg, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01244126     History of Changes
Other Study ID Numbers: H-21839
First Submitted: September 16, 2010
First Posted: November 19, 2010
Results First Submitted: August 9, 2013
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016