Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000279527
Ethics application status
Approved
Date submitted
14/11/2023
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain treatment during and after major surgery in neonates born with oesophageal atresia.
Scientific title
Retrospectively assessment of opioid consumption peri and postoperatively in newborns with oesophageal atresia who received paravetrebral blockage.
Secondary ID [1] 310958 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 332037 0
Oesophageal atresia.
 332038 0
Condition category
Condition code
Anaesthesiology 328764 328764 0 0
Pain management
Oral and Gastrointestinal 329304 329304 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 329305 329305 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A Retrospective observational study.

A retrospective comparison between patients receiving paravertebral analgesia and those
who only had intravenous analgesia peri and postoperatively
.
No active participation only data collection from medical journal systems.

Data is to be collected concerning the patients gender, postnatal age, weight, amount opioids given during and after surgery, Time in Pediatric Intensive Care Unit (PICU) as well as in hospital. Time on ventilator and wound healing,Type of regional anesthesia eg. paravertebral block. Information of what kind of analgesic drugs that has been used
.
The overall duration of observation time is from admission to the surgical unit before surgery until discharge from hospital.

The data is being retrospectively collected from medical journals at Karolinska university hospital from 1st Jan 2020-31st dec 2023.
Intervention code [1] 327387 0
Not applicable
Comparator / control treatment
Only retrospective comparison is made between the groups.
Comparator is patients with the same condition who has not received an paravertebral block during surgery but only peri and postoperative analgesia based on intravenous drugs with opioids as a base. This is the "default" treatment in this patient category in our clinic.
Control group
Active

Outcomes
Primary outcome [1] 336571 0
Amounts of opioids given intraoperatively during surgery
Timepoint [1] 336571 0
Perioperatively
Primary outcome [2] 336572 0
Amounts of opioids given at the Pediatric Intensive Care Unit (PICU)
Timepoint [2] 336572 0
Assessed until the patients left the Pediatric Intensive Care Unit (PICU)
Primary outcome [3] 336573 0
Length of stay at the Pediatric Intensive Care Unit
Timepoint [3] 336573 0
Assessed at discharge from Pediatric intensive Care Unit.
Secondary outcome [1] 428833 0
Length of hospital stay
Timepoint [1] 428833 0
Assessed at discharge from our hospital.
Secondary outcome [2] 428834 0
Wound healing
Timepoint [2] 428834 0
Assessed until the patient left the hospital.
Secondary outcome [3] 428835 0
Time to enteral feeding (beginning and full)
Timepoint [3] 428835 0
Assessed until the patient left the hospital

Eligibility
Key inclusion criteria
Newborn infants who went through surgery due to oesophageal atresia at Karolinska university hospital during the years 2020-2023
Minimum age
No limit
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active parental denial to search for information in the infants medical records
Long gap oesophageal atresia
Severe known genetic disorders including trisomias

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 25967 0
Sweden
State/province [1] 25967 0

Funding & Sponsors
Funding source category [1] 315217 0
Hospital
Name [1] 315217 0
Karolinska University Hospital
Country [1] 315217 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University hospital
Address
Eugeniavägen 23, 171 64 Solna, Sweden
Country
Sweden
Secondary sponsor category [1] 317249 0
None
Name [1] 317249 0
Address [1] 317249 0
Country [1] 317249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314141 0
Etikprövningsmyndigheten Uppsala
Ethics committee address [1] 314141 0
Ethics committee country [1] 314141 0
Sweden
Date submitted for ethics approval [1] 314141 0
04/05/2023
Approval date [1] 314141 0
31/05/2023
Ethics approval number [1] 314141 0
2023-02907-01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130562 0
Dr Marie Anell Olofsson
Address 130562 0
Karolinska University Hospital , Eugenia vägen 23, 171 64 Solna, Sweden
Country 130562 0
Sweden
Phone 130562 0
+46734389232
Fax 130562 0
Email 130562 0
marie.anell-olofsson@regionstockholm.se
Contact person for public queries
Name 130563 0
Camilla Linnarsson
Address 130563 0
Karolinska University Hospital , Eugenia vägen 23, 171 64 Solna, Sweden
Country 130563 0
Sweden
Phone 130563 0
+46702314891
Fax 130563 0
Email 130563 0
camilla.linnarsson@regionstockholm.se
Contact person for scientific queries
Name 130564 0
Camilla Linnarsson
Address 130564 0
Karolinska University Hospital , Eugenia vägen 23, 171 64 Solna, Sweden
Country 130564 0
Sweden
Phone 130564 0
+46702314891
Fax 130564 0
Email 130564 0
camilla.linnarsson@regionstockholm.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to small material there is a small risk for identification of the participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.