Clinical Trial Results:
Pain relief of methoxyflurane in patients with burns
Summary
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EudraCT number |
2020-005865-14 |
Trial protocol |
DK |
Global end of trial date |
29 Aug 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Sep 2022
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First version publication date |
16 Sep 2022
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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 |
2020110357
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Inge Lehmanns Vej 6, Copenhagen, Denmark, DK-2100
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Public contact |
Dept Anaesthesia, Rigshospitalet, 45 35458043, lars.rasmussen.01@regionh.dk
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Scientific contact |
Dept Anaesthesia, Rigshospitalet, 61652212 35458043, lars.rasmussen.01@regionh.dk
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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 |
29 Aug 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Aug 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Aug 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess pain relief of methoxyflurane in patients with burns undergoing change of wound dressing
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Protection of trial subjects |
Basic pain relief provided
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Background therapy |
Paracetamol, NSAID and opiods provided for basic pain relief | ||
Evidence for comparator |
No comparator | ||
Actual start date of recruitment |
25 Jun 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Denmark: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was undertaken at Copenhagen University Hospital, Rigshospitalet, 25th of June 2021 to 31st of July 2022 | ||||||
Pre-assignment
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Screening details |
We screened burn patients at least 18 years and able to give informed consent. | ||||||
Period 1
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
No blinding
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Arms
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Arm title
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Methoxyflurane | ||||||
Arm description |
Burn patients receiving methoxyflurane | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Penthrox
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Inhalation vapour, solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Self administered inhalation through specific device containing 3 ml
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
All
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients
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End points reporting groups
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Reporting group title |
Methoxyflurane
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Reporting group description |
Burn patients receiving methoxyflurane | ||
Subject analysis set title |
All
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All patients
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End point title |
Maximal pain during the procedure [1] | ||||||||
End point description |
Maximal pain as expressed by patient
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End point type |
Primary
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End point timeframe |
During procedure with change of dressing
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No test done |
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No statistical analyses for this end point |
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End point title |
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 |
Nurse's assessment of pain | ||||||||
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 |
Oxygen saturation | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Lowest during 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 |
Seven days
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Assessment type |
Systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||
Dictionary version |
2022AA
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Reporting groups
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Reporting group title |
All exposed
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Reporting group description |
Burn patients exposed to methoxyflurane | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||
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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. | |||
Slow recruitment |