Condition category
Surgery
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
07/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof D. Tibboel

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s Hospital
Department of Pediatric Surgical Intensive Care
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636567
j.illsley@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EVIAN

Study hypothesis

To investigate whether epidural analgesia provides a better postoperative pain control than intravenous (iv) opioid analgesia in children and whether epidural analgesia is associated with reduced postoperative morbidity.

Ethics approval

Not provided at time of registration

Study design

Double-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pain during thoracic and abdominal surgery

Intervention

Patient controlled intravenous analgesia versus patient controlled epidural analgesia

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain intensity
2. Epidural or iv analgesics consumption
3. Side effects

Secondary outcome measures

Secondary hyperalgesia

Overall trial start date

08/05/2006

Overall trial end date

08/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 6-18 years
2. American Society of Anesthesiologists (ASA) I or II

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Preoperative use of analgesics or opioids for (chronic) pain syndromes
2. Endocrine and neurological disorders
3. Psychiatric disorders
4. Peripheral neuropathy
5. Mental retardation
6. Medication influencing somatosensory function
7. Indifference or insensitivity to pain
8. Contraindications to epidural analgesia
9. Contraindications to self-administration of opioids

Recruitment start date

08/05/2006

Recruitment end date

08/11/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Department of Anesthesiology (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Erasmus Medical Center

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes