No registrations found.
ID
Source
Brief title
Health condition
elective upper/lower abdominal, urological or thoracic surgery
Sponsors and support
Head of Pediatric Surgical Intensive Care
Erasmus MC- Sophia Children's Hospital
Dr. Molewaterplein 60
3015 GJ Rotterdam
T +31 10 4636567
Intervention
Outcome measures
Primary outcome
1. Pain intensity;
2. Epidural/iv analgesics consumption;
3. Side effects.
Secondary outcome
Secondary hyperalgesia.
Background summary
Systemic 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.
Study objective
To 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.
Study design
N/A
Intervention
Patient controlled intravenous analgesia versus patient controlled epidural analgesia.
Sophia Children’s Hospital <br>
Department of Pediatric Surgical Intensive Care
D. Tibboel
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636567
j.illsley@erasmusmc.nl
Sophia Children’s Hospital <br>
Department of Pediatric Surgical Intensive Care
D. Tibboel
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636567
j.illsley@erasmusmc.nl
Inclusion criteria
1. 6-18 years;
2. ASA I or II.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL605 |
| NTR-old | NTR662 |
| Other | : N/A |
| ISRCTN | ISRCTN94873343 |