Epidural versus intravenous analgesia in children: a double-blind randomized controlled trial.
| ISRCTN | ISRCTN94873343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94873343 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center, Department of Anesthesiology (The Netherlands) |
| Funder | Erasmus Medical Center |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Pain intensity |
| Key secondary outcome measure(s) |
Secondary hyperalgesia |
| Completion date | 08/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
