Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28626
Enrollment
60
Registered
2006-04-25
Start date
2006-05-08
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elective upper/lower abdominal, urological or thoracic surgery

Interventions

Patient controlled intravenous analgesia versus patient controlled epidural analgesia.

Sponsors

D. Tibboel, MD, PhD Head of Pediatric Surgical Intensive Care Erasmus MC- Sophia Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam T +31 10 4636567
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 6-18 years; 2. ASA I or II.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
1. Pain intensity; 2. Epidural/iv analgesics consumption; 3. Side effects.

Secondary

MeasureTime frame
Secondary hyperalgesia.

Contacts

Public ContactD. Tibboel

Erasmus Medical Center Sophia Children’s Hospital Department of Pediatric Surgical Intensive Care

j.illsley@erasmusmc.nl+31 (0)10 4636567

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)