Clinical Trial Results:
A prospective randomized double-blind study
Intranasal dexmedetomidine versus intranasal S-ketamine for children age
1 – 3 years for procedural sedation and analgesia in pediatric emergency
department.
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Summary
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EudraCT number |
2017-000057-40 |
Trial protocol |
SE |
Global end of trial date |
28 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2023
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First version publication date |
19 Dec 2023
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Other versions |
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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_vs_ket
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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 |
18 Nov 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Oct 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Oct 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 |
The aim of this study is to measure whether intranasal dexmedetomidine
can provide better, faster onset of action and more effective, analgesia
and sedation during procedure than intranasal S-ketamine among
children between 1 and 3 years of age with minor injuries with respect
to analgesia measured by FLACC in a prospective randomized doubleblind
study.
We are interested in finding out if intranasal dexmedetomidine could be
used for PSA for painful procedures in combination with local anesthesia.
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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: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
15
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Children (2-11 years) |
15
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Adolescents (12-17 years) |
0
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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 July 2017 and October 2019 | |||||||||
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Pre-assignment
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Screening details |
Children 1 - 3 years old who presented to the ALB ED with a laceration in need of suturing or a burn covering less than 4% of the body surface area were eligible for enrolment. | |||||||||
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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 |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer | |||||||||
Blinding implementation details |
A physician not participating in the trial created a randomization list after a random draw and filled the envelopes with information (trial medicine and dose table) and numbered them according to the list. Envelopes were then used in number order.
The trial physician, ED physician and nurses caring for the patient, as well as the patient and parents were blinded to the medication, as were all other staff working in the ED.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IN DEX | |||||||||
Arm description |
Subjects received 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 for solution for injection/infusion
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Routes of administration |
Intranasal use
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Dosage and administration details |
Dexmedetomidine 100 mcg/ml without dilution. A 1 ml syringe with a nasal atomizer was used for drug administration. Dose 2.0 mikrog/kg
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Arm title
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IN KET | |||||||||
Arm description |
Subjects received intranasal esketamine for procedural sedation and analgesia. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
esketamine
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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 |
Esketamine 25 mg/ml was used without dilution. A 1 ml syringe with a nasal atomizer was used for drug administration. Dose 1.0 mg/kg
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Baseline characteristics reporting groups
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Reporting group title |
IN DEX
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Reporting group description |
Subjects received intranasal dexmedetomidine for procedural sedation and analgesia. | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IN KET
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Reporting group description |
Subjects received intranasal esketamine 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 |
Subjects received intranasal dexmedetomidine for procedural sedation and analgesia. | ||
Reporting group title |
IN KET
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Reporting group description |
Subjects received intranasal esketamine 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 ket | |||||||||
Comparison groups |
IN DEX v IN KET
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Median difference (final values) | |||||||||
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 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 |
Physicians 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 [1]
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Timeframe for reporting adverse events |
July 2017 - October 2019
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Adverse event reporting additional description |
Reported to Swedish Medical authority
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Assessment type |
Systematic | |||||||||||||||
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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 |
esketamine
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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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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No serious or non-serious adverse events were reported in this trial. |
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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 | |||
