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Epidural versus intravenous analgesia in children; a double-blind randomized controlled trial.


- candidate number2072
- NTR NumberNTR662
- ISRCTNISRCTN94873343
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR25-apr-2006
- Secondary IDsN/A 
- Public TitleEpidural versus intravenous analgesia in children; a double-blind randomized controlled trial.
- Scientific TitleEpidural versus intravenous analgesia in children; a double-blind randomized controlled trial.
- ACRONYMEVIAN
- hypothesisTo investigate whether epidural analgesia provides a better postoperative pain control than intravenous opioid analgesia in children and whether epidural analgesia is associated with reduced postoperative morbidity.
- Healt Condition(s) or Problem(s) studiedAbdominal surgery, Thoracic surgery
- Inclusion criteria1. 6-18 years;
2. ASA I or II.
- Exclusion criteria1. Preoperative use of analgesics/opioids(chronic) pain syndromes;
2. Endocrine and neurological disorders;
3. Psychiatric disorders;
4. Peripheral neuropathy;
5. Mental retardation;
6. Medication influencing somatosensory function;
7. Indifference/insensitivity to pain;
8. Contraindications to epidural analgesia;
9. Contraindications to self-administration of opioids.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-mei-2006
- planned closingdate8-nov-2006
- Target number of participants60
- InterventionsPatient controlled intravenous analgesia versus patient controlled epidural analgesia.
- Primary outcome1. Pain intensity;
2. Epidural/iv analgesics consumption;
3. Side effects.
- Secondary outcomeSecondary hyperalgesia.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf.Dr. D. Tibboel
- CONTACT for SCIENTIFIC QUERIESdrs. H. Blussť van Oud-Alblas
- Sponsor/Initiator Erasmus Medical Center, Department of Anesthesiology, Erasmus Medical Center, Sophia Children's Hospital, Department of Pediatric Surgical Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summarySystemic opioids and epidural analgesia are for major thoracic/abdominal surgery the two most common forms of postoperative analgesia both in adutls as in children. In adults epidural analgesia has beneficial effects on postoperative outcome and provides better pain control than intravenous opioids. In children however there is limited objective evidence that epidural analgesia after major surgery is more effective than intravenous opioid analgesia. Next to this it is unclear if the adverse effect profiles differ with both techniques. Aim of this study is to investigate whether epidural analgesia provides better postoperative pain control than intravenous analgesia in children and to find out whether epidural analgesia is associated with reduced postoperative morbidity.
- Main changes (audit trail)
- RECORD25-apr-2006 - 9-sep-2009


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