Clinical Trial Results:
Pharmacokinetic study of the opioid ketobemidone in children and adolescens after intravenous administration
Summary
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EudraCT number |
2006-006717-32 |
Trial protocol |
SE |
Global end of trial date |
03 Jun 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
21 May 2021
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First version publication date |
21 May 2021
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Other versions |
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Summary report(s) |
Published article 2009 |
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 |
554
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Ethics committee Karolinska Institutet Stockholm : 2007/4:1 | ||
Sponsors
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Sponsor organisation name |
Stockholms Läns Landsting
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Sponsor organisation address |
Karolinska University Hospital, Stockholm, Sweden, 17176
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Public contact |
Stefan Lundeberg, Karolinska University Hospital, +46 851777189, stefan.lundeberg@sll.se
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Scientific contact |
Pediatric Pain treatment Service, Karolinska University Hospital, +46 851770000, stefan.lundeberg@sll.se
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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 Jun 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Apr 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jun 2008
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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 |
Determination of elimination half life of ketobemidone after intravenous injection in children
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Protection of trial subjects |
Postoperative pain management following standard protocol at the hospital. The study drug was part of the pain treatment.
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Background therapy |
Standard analgesic treatment with paracetamol, clonidine and opioids as needed. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
10 Sep 2007
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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) |
5
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Infants and toddlers (28 days-23 months) |
15
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Children (2-11 years) |
10
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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 |
30 children who underwent a planned surgical procedure and in need of postoperative opioid treatment. | ||||||
Pre-assignment
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Screening details |
31 children were screened and 30 participated and consent was given. | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not applicable
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Arms
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Arm title
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Ketobemidone | ||||||
Arm description |
Study drug used for all enrolled patients | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Ketobemidone hydrochloride
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Investigational medicinal product code |
N02AB01
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
0.05 mg/kg for neonates and up to 3 months of age, 0.1 mg/kg over the age of 3 months.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Three groups: neonates up to 90 days; 1-2.5 years; 7-10 years | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Ketobemidone plasma concentration
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Plasma concentration of ketobemidone were analysed. Blood sampling was perfomed at 6 occasions after bolus dose was given.
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Subject analysis set title |
Ketobemidone comparison group
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Age groups as described
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End points reporting groups
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Reporting group title |
Ketobemidone
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Reporting group description |
Study drug used for all enrolled patients | ||
Subject analysis set title |
Ketobemidone plasma concentration
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Plasma concentration of ketobemidone were analysed. Blood sampling was perfomed at 6 occasions after bolus dose was given.
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Subject analysis set title |
Ketobemidone comparison group
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Age groups as described
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End point title |
Pharmacokinetic parameter | ||||||||||||
End point description |
Last patient enrolled
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End point type |
Primary
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End point timeframe |
September 2007 to April 2008
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Statistical analysis title |
AUC | ||||||||||||
Statistical analysis description |
AUC /mg/kg in relation to age groups
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Comparison groups |
Ketobemidone comparison group v Ketobemidone plasma concentration
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Number of subjects included in analysis |
48
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Analysis specification |
Post-hoc
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Analysis type |
other [1] | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Spearman Rank Correlation | ||||||||||||
Confidence interval |
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Notes [1] - comparison between age groups |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From time of administration of bolus dose of ketobemidone and up to 72 hours post injection.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CRF protocol | ||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Ketobemidone
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Reporting group description |
Children administered a bolus dose of ketobemidone | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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: Nausea was registered in 2 patients but this might have been caused by several factors as the surgical procedure, the anesthesia as well as the post operative analgesics including ketobemidone or other given opioids |
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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. | |||
Nausea as a non serious side effects could be explained by many factors including the use of ketobemidone, surgical procedure and anesthesia. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/19839946 |