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
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