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Caudal Analgesia in Pediatric Laparoscopic Surgery

Evaluation of Caudal Bupivacaine with Clonidine versus Caudal Bupivacaine alone in hemodynamic responses and analgesic effects in Pediatric Laparoscopic surgery - PEDSCAUDAL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006911
Enrollment
48
Registered
2016-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children (6 months -6 years) undergoing elective laparoscopic surgery Health Condition 2: N29- Other disorders of kidney and ureter in diseases classified elsewhere

Interventions

Intervention1: Caudal bupivacaine: Analgesia during laparoscopic surgery Intervention2: caudal bupivacaine with clonidine: Analgesia during laparoscopic surgery Control Intervention1: Normal Saline: P

Sponsors

Amrita Institute of Medical Sciences and research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective laparoscopic surgery

Exclusion criteria

Exclusion criteria: 1. Patient/parent Refusal 2. Local site infection or anatomical abnormality. 3. Coagulopathy or an INR > 1.5 4. ASA grades III and above 5. Complex congenital heart diseases 6. Hemodynamic Instability needing inotropes preoperatively.

Design outcomes

Primary

MeasureTime frame
Hemodynamic response and analgesic use during the surgeryTimepoint: Port insertion and 30 min intervals during surgery. Total analgesic use for the duration of surgery.

Secondary

MeasureTime frame
1. Total analgesic used and need for top ups. Intraoperatively (mcg/kg/hr). 2. Recovery score at extubation. 3. Adverse events.(Delayed motor recovery, hypotension, bradycardia requiring intervention and delayed recovery from anesthesia) 4. Postoperative pain scores & analgesic requirement in the 24 hours. Timepoint: At extubation and every 4 hours in the ICU till transfer out of ICU

Countries

India

Contacts

Public ContactLakshmi Kumar

Amrita Institute of Medical Sciences and Research Center

lakshmi.k.238@gmail.com04842856162

Outcome results

None listed

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