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.
ID
Bron
Verkorte titel
Aandoening
elective upper/lower abdominal, urological or thoracic surgery
Ondersteuning
Head of Pediatric Surgical Intensive Care
Erasmus MC- Sophia Children's Hospital
Dr. Molewaterplein 60
3015 GJ Rotterdam
T +31 10 4636567
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Pain intensity;<br>
2. Epidural/iv analgesics consumption;<br>
3. Side effects.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patient controlled intravenous analgesia versus patient controlled epidural analgesia.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 6-18 years;
2. ASA I or II.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL605 |
| NTR-old | NTR662 |
| Ander register | : N/A |
| ISRCTN | ISRCTN94873343 |