Clinical Trial Results:
A prospective randomized open label study
Intranasal dexmedetomidine versus inhaled nitrous oxide for children age 3 – 15 years for procedural sedation and analgesia in pediatric emergency department.
Summary
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EudraCT number |
2016-003773-17 |
Trial protocol |
SE |
Global end of trial date |
28 Aug 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Feb 2024
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First version publication date |
19 Feb 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
dex_version1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Karolinska University Hospital
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Sponsor organisation address |
AnnaStecksens gatan, Stockholm, Sweden,
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Public contact |
Astrid Lindgrens Childrens hospital, Karolinska University Hospital, 46 851770000,
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Scientific contact |
Astrid Lindgrens Childrens hospital, Karolinska University Hospital, 46 851770000,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Dec 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Aug 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Aug 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Aim of this study is to measure whether intranasal dexmedetomidine is equally good as nitrous oxide (N2O) among children between 3 and 15 years of age with minor injuries with respect to analgesia during procedure measured by FLACC in a prospective randomized open-label study.
We are interested in finding out if dexmedetomidine could be used for PSA for painful procedures in combination with local anesthetics.
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Protection of trial subjects |
This trial was approved by the Swedish Ethical Review Authority, Stockholm.
As all subject enrolled in this trial were minors and therefore vulnerable the risks and benefits of the treatments were carefully assessed.
Informed consent was required from all caregivers.
All data has been treated anonymously.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 May 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 156
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Worldwide total number of subjects |
156
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EEA total number of subjects |
156
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
117
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Adolescents (12-17 years) |
39
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patient recruitment was carried out in the pediatric ED at Astrid Lindgren Children’s hospital (ALB), Karolinska University Hospital in Stockholm, Sweden between August 2017 and October 2020 | |||||||||||||||
Pre-assignment
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Screening details |
Swedish speaking, previously healthy children aged 3 to 15 years with an extremity fracture or luxation requiring reduction were eligible for this study. | |||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IN DEX | |||||||||||||||
Arm description |
Intranasal dexmedetomidine for procedural sedation and analgesia | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
dexmedetomidine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intranasal use
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Dosage and administration details |
2.0 mcg/kg intranasal with mucosal athomization devize (MAD)
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Arm title
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Nitrous oxide | |||||||||||||||
Arm description |
Inhaled Nitrous oxide for procedural sedation and analgesia | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
nitrous oxide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicinal gas, compressed
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Routes of administration |
Inhalation use
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Dosage and administration details |
N2O was administered with a facial mask held by an experienced ED nurse. N2O was titrated to a concentration 50% N2O : 50% O2 within 2-3 minutes. When N2O was discontinued supplemental 100% O2 was provided for 2-3 minutes.
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Baseline characteristics reporting groups
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Reporting group title |
IN DEX
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Reporting group description |
Intranasal dexmedetomidine for procedural sedation and analgesia | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nitrous oxide
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Reporting group description |
Inhaled Nitrous oxide for procedural sedation and analgesia | ||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IN DEX
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Reporting group description |
Intranasal dexmedetomidine for procedural sedation and analgesia | ||
Reporting group title |
Nitrous oxide
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Reporting group description |
Inhaled Nitrous oxide for procedural sedation and analgesia |
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End point title |
pain | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
After procedure
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Statistical analysis title |
dex vs N2O | |||||||||
Comparison groups |
Nitrous oxide v IN DEX
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Number of subjects included in analysis |
155
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
sedation | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After procedure
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No statistical analyses for this end point |
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End point title |
parental and patient satisfaction | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After procedure
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No statistical analyses for this end point |
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End point title |
phycisians opinion | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After procedure
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
August 2018 - August 2020
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Adverse event reporting additional description |
Reported to Swedish Medical authority
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2.1
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Reporting groups
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Reporting group title |
dexmedetomidine
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Reporting group description |
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Reporting group title |
Nitrous oxide
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 0.7% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |