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Epidural analgesia versus intravenous fentanyl infusion in children with cerebral palsy undergo major orthopedic surgery: Randomized Controlled Trial

Epidural analgesia versus intravenous fentanyl infusion in children with cerebral palsy undergo major orthopedic surgery: Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160215002
Enrollment
34
Registered
2016-02-15
Start date
2016-01-03
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

cerebral palsy Epidural analgesia Intravenous fentanyl infusion Postoperative pain control Cerebral palsy Major orthopedic surgery

Interventions

caudal block single shot technique loss of resistence at sacral hiatus drug 0.25%bupivacaine 1ml/kg after intubation And start infusion intravenous fentanyl after finish operation with drug fentanyl0.
epidural block technique loss of resistant at L3&#45
4 or L4&#45
5 after intubation and test dose with 0.25% bupivacaine with adrenaline 1:200&#44
000 0.1 ml/kg &#45
intraoperative give 0.25% bupivacaine 0.3 ml/kg for loading and 0.25% bupivacaine 0.2 ml/kg q 2 hr &#45
Start infusion epidural solution after finish operation with 0.1% bupivacaine 0.3 ml/kg/hr with fentanyl 1 mcg/ml
Experimental Procedure/Surgery,Experimental Procedure/Surgery
intravenous fentanyl infusion group,epidural analgesia group

Sponsors

Queen Sirikit National Institute of Child Health
Lead Sponsor
Queen Sirikit National Institute of Child Health
Collaborator

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years

Inclusion criteria

Inclusion criteria: - cerebral palsy - Age 1–15 year - major orthopedic surgery

Exclusion criteria

Exclusion criteria: - drug allergy - contraindication for epidural block - recieve pain control before surgery - ASA classification > III

Design outcomes

Primary

MeasureTime frame
number of patients who have moderate to severe pain after surgery 8,16,24 hr Non-Communicating Children's Pain Checklist-Postoperative Version (NCCPC-PV)

Secondary

MeasureTime frame
Postoperative complication 24 hr Question and criteria

Countries

thailand

Contacts

Public Contactprathana wittayapairoch

Queen Sirikit National Institute of Child Health

yorjung@hotmail.com+66 896222682

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026