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Comparison of postoperative pain relief between caudal epidural morphine and intrathecal morphine in children undergoing surgery for anorectal malformations, exstrophy bladder, complex urogenital procedures, lower abdominal infra umbilical surgeries performed through Pfannenstiel incision.

Double blind randomized controlled trial for comparison of postoperative pain relief between epidural morphine and intrathecal morphine for definitive correction of ano-rectal malformation in paediatric patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037509
Enrollment
40
Registered
2021-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K628- Other specified diseases of anus and rectum Health Condition 3: N328- Other specified disorders of bladder Health Condition 4: N398- Other specified disorders of urinary system

Interventions

Intervention1: Spinal(Group S): Intrathecal Morphine(4mcg/kg) with 0.5% (H) Bupivacaine(0.4mg/kg for 5-15 kg,0.3mg/kg 15 kg) through spinal route Control Intervention1: Caudal (Group C): Administratio

Sponsors

All India Institute of Medical SciencesNew Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children posted for definitive correction of anorectal malformations, exstrophy bladder, complex urogenital procedures, ureteric re-implantation, lower abdominal infra-umbilical surgery and surgical procedures performed through Pfannenstiel incision

Exclusion criteria

Exclusion criteria: (a) Severe and significant Congenital Heart Disease (b) Sacral Malformation (c) Previous Neurological Deficit (d) Bleeding diathesis (e) Parental Refusal (f) Weight

Design outcomes

Primary

MeasureTime frame
To compare the safety and efficacy of Caudal morphine and Intrathecal morphineTimepoint: FLACC-/3hrs Salivary Cortisol, serum cortisol-Preoperative,Postoperative, Next day—

Secondary

MeasureTime frame
Nausea and VomittingTimepoint: Postoperative;parental satisfactionTimepoint: 12 & 24 hours after surgery;Postoperative Pain reliefTimepoint: /3hrs, Next day—

Countries

India

Contacts

Public ContactRajeshwari Subramaniam

All India Institute of Medical Sciences

drsrajeshwari@gmail.com9810079229

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026