Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Midazolam in Children as a Pre-Operative Sedative

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314546
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
David A Ullman MD, Bassett Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sedation, Conscious
Interventions Drug: Midazolam
Drug: xylocaine
Drug: saline placebo
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description Control patients received intranasal saline. Patients received 0.2 mg/kg of intranasal midazolam Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Period Title: Overall Study
Started 5 5 5
Completed 5 5 5
Not Completed 0 0 0
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine Total
Hide Arm/Group Description Control patients received intranasal saline. Patients received 0.2 mg/kg of intranasal midazolam Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 15
Hide Baseline Analysis Population Description
It was determined that a minimum of 15 patients (5 in each group) were necessary for baseline statistical analysis of this pilot study, to be used in performing a formal power analysis and sample size calculation. However, limitations in the number of providers and eligible patients during the two-year study period prevented further recruitment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 15 participants
3.2  (2.2) 4.0  (1.2) 4.0  (2.0) 3.7  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
Female
2
  40.0%
1
  20.0%
1
  20.0%
4
  26.7%
Male
3
  60.0%
4
  80.0%
4
  80.0%
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 5 participants 15 participants
5 5 5 15
American Society of Anesthesiologists Physical Status Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 15 participants
ASA Class 1 1 2 2 5
ASA Class 2 4 3 3 10
[1]
Measure Description: ASA Class 1: A healthy patient, ASA Class 2: A patient with mild systemic disease
1.Primary Outcome
Title Sedation Scale Score
Hide Description Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time Frame 10 minutes post-sedation
Hide Outcome Measure Data
Hide Analysis Population Description
participants with available data at this time point
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 4 4 5
Measure Type: Number
Unit of Measure: participants
Agitated 0 0 0
Alert 1 2 2
Calm 3 2 3
Drowsy 0 0 0
Asleep 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Sedation Scale Score
Hide Description Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time Frame 15 minutes post-sedation
Hide Outcome Measure Data
Hide Analysis Population Description
participants with available data at this time point
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 4 3 3
Measure Type: Number
Unit of Measure: participants
Agitated 0 0 0
Alert 1 1 1
Calm 3 2 2
Drowsy 0 0 0
Asleep 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Time From Administration to Discharge
Hide Description [Not Specified]
Time Frame Minutes from administration to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: minutes
87.0  (21.9) 74.2  (9.6) 97.0  (18.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Parental Observed Behavioral Distress Score
Hide Description Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Time Frame 1 minute post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.08  (0.2) 3.10  (2.4) 1.96  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title RN Observed Behavioral Distress Score
Hide Description Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Time Frame 1 minute post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients will received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (0.2) 2.4  (3.0) 1.9  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Secondary Outcome
Title Verbal Complaint
Hide Description Recorded by the administering RN at the time of administration.
Time Frame At time of administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 5 5 5
Measure Type: Number
Unit of Measure: participants
No Complaint 3 1 2
Complaint Reported 2 4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Verbal Complaints
Hide Description Recorded by the administering RN at one minute post-administration
Time Frame 1 minute post-administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description:
Control patients received intranasal saline.
Patients received 0.2 mg/kg of intranasal midazolam
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
Overall Number of Participants Analyzed 5 5 5
Measure Type: Number
Unit of Measure: participants
No Complaint 5 3 4
Complaint Reported 0 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline Placebo, Nasal Midazolam Only, Midazolam Plus Xylocaine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame During hospital stay.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Hide Arm/Group Description Control patients received intranasal saline. Patients received 0.2 mg/kg of intranasal midazolam Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
All-Cause Mortality
Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Placebo Nasal Midazolam Only Midazolam Plus Xylocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Limitations in the number of providers and eligible patients during the two-year study period.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David A. Ullman, MD, Senior Attending Anesthesiologist
Organization: Bassett Healthcare Network
Phone: 607-547-3153
EMail: david.ullman@bassett.org
Layout table for additonal information
Responsible Party: David A Ullman MD, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02314546     History of Changes
Other Study ID Numbers: 994
First Submitted: December 3, 2014
First Posted: December 11, 2014
Results First Submitted: January 28, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015