Epidural versus intravenous analgesia in children: a double-blind randomized controlled trial.
| ISRCTN | ISRCTN94873343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94873343 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/06/2006
- Registration date
- 07/06/2006
- Last edited
- 07/06/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof D. Tibboel
Scientific
Scientific
Erasmus Medical Center
Sophia Children’s Hospital
Department of Pediatric Surgical Intensive Care
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636567 |
|---|---|
| j.illsley@erasmusmc.nl |
Study information
| Study design | Double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | EVIAN |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pain during thoracic and abdominal surgery |
| Intervention | Patient controlled intravenous analgesia versus patient controlled epidural analgesia |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain intensity 2. Epidural or iv analgesics consumption 3. Side effects |
| Secondary outcome measures | Secondary hyperalgesia |
| Overall study start date | 08/05/2006 |
| Completion date | 08/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. 6-18 years 2. American Society of Anesthesiologists (ASA) I or II |
| Key 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 |
| Date of first enrolment | 08/05/2006 |
| Date of final enrolment | 08/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Center, Department of Anesthesiology (The Netherlands)
University/education
University/education
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
University/education
Erasmus Medical Center
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
