Clinical Trial Results:
Ultrasound Guided Caudal Blockade in Children between 30 and 50kg: A Feasibility Study
Summary
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EudraCT number |
2013-002359-14 |
Trial protocol |
AT |
Global end of trial date |
28 Sep 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Mar 2021
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First version publication date |
05 Mar 2021
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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 |
1.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
DRKS number: DRKS00005021 | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Klaus Markstaller(Sponsor), contact person: Daniela Marhofer, Med. Universität Wien, Universitätsklinik für Anästhesie, Allg. Intesnivmedizin&Schmerztherapie, +43 14040041020, daniela.marhofer@meduniwien.ac.at
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Scientific contact |
Klaus Markstaller(Sponsor), contact person: Daniela Marhofer, Med. Universität Wien, Universitätsklinik für Anästhesie, Allg. Intesnivmedizin&Schmerztherapie, +43 14040041020, daniela.marhofer@meduniwien.ac.at
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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 |
28 Sep 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Sep 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Sep 2015
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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 |
Caudal block is possible for children between 30 and 50kg body weight, no additional analgesic drugs were required during surgery
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Protection of trial subjects |
Anonymisation of the data, no name will be published, only iniditals
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Background therapy |
Premedication consisted in midazolam orally or iv. All children received an infusion of Elo-Mel isotone at a rate of 5 ml kg-1 h-1. General anaesthesia was induced with propofol 10 mg •ml-1 at 2−4 mg kg-1 and fentanyl 1 µg kg-1 to facilitate the insertion of a laryngeal mask. Anaesthesia was then maintained with sevoflurane at 1 MAC (end-expiratory) via laryngeal mask and spontaneous respiration. Where pre-induction establishment of a venous access was not possible, inhalation anaesthesia with sevoflurane 8 vol% was used for induction. | ||
Evidence for comparator |
Caudal anaesthesia is a common anaesthesiological procedure for children less than 25kg body weight | ||
Actual start date of recruitment |
30 Jul 2014
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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 |
Austria: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
9
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Adolescents (12-17 years) |
11
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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 |
Patients who have to undergo subumbilical surgery with a body weight 30-50kg are recruited in the Deaprtment of paediatric surgery. | ||||||
Pre-assignment
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Screening details |
Subjects undergo subumbilical surgery with a body weight 30-50kg | ||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||
Number of subjects completed |
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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 | ||||||
Arms
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Arm title
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Caudal block for children with a body weight 30-50kg | ||||||
Arm description |
Children with a body weight 30-50kg has to undergo caudal block are recruitted | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Ropivacaine 3.1mg/ml
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Investigational medicinal product code |
Ropivacaine
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Epidural use
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Dosage and administration details |
1ml/kg bodyweight Ropivacaine 3.1mg/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 |
Overall trial
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Children with a body weight 30-50kg has to undergo caudal block are recruitted
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End points reporting groups
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Reporting group title |
Caudal block for children with a body weight 30-50kg
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Reporting group description |
Children with a body weight 30-50kg has to undergo caudal block are recruitted | ||
Subject analysis set title |
Overall trial
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Children with a body weight 30-50kg has to undergo caudal block are recruitted
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End point title |
Feasibility of a successful block | |||||||||
End point description |
Feasibility of the caudal blockades in children with a body weight 30-50kg. If there are any movements of extremities or haemodynamic changes of 15% at time of skin incision the caudal block would have been considered as "unsuccessful".
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End point type |
Primary
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End point timeframe |
The block has to work 15 minutes after performing the block
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Statistical analysis title |
Descriptive Analysis, Pearson's correlation | |||||||||
Statistical analysis description |
The presence of a normal distribution was checked by a one-sample Kolmogorov-Smirnov test, using statistical software (IBM SPSS Statistics, v. 20; IBM, Armonk, NY, USA). All data were descriptively analysed. Pearson’s correlation coefficient was used to evaluate associations between pharmacodynamics and body weight
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Comparison groups |
Caudal block for children with a body weight 30-50kg v Overall trial
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
= 0 [2] | |||||||||
Method |
Pearson's correlation | |||||||||
Parameter type |
correlation coefficient | |||||||||
Confidence interval |
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Notes [1] - clinical case series study of feasibility [2] - no p-value |
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Adverse events information [1]
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Timeframe for reporting adverse events |
study period
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Adverse event reporting additional description |
failed block is predefined by a movement while skin inzision, preoperatively monitoring of the vital parameters (non invasive blood pressure, egg, oxygen saturation), neurological evaluation
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
n.a. | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
failed block
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Reporting group description |
failed block is predefined by a movment while the skin incision | ||||||||||
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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: clinical case series study of feasibility none AE |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Feb 2014 |
Protocol change: after 4 participants an amendment was done: instead of caudal block and sedation, general anaesthesia with larnygeal mask but under spontanous ventilation would be done. Reason: the need of sedation medication was too high, general anaesthesia under spontanous ventilation would be better and easier |
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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. | |||
no limitations and caveats |