This study is being done to find out which medicine, Dexmedetomidine or Fentanyl, gives better and longer pain relief when mixed with Bupivacaine in children undergoing lower abdominal or lower body surgeries.

A PROSPECTIVE, RANDOMIZED, COMPARATIVE STUDY ON THE EFFICACY OF DEXMEDETOMIDINE VS FENTANYL AS AN ADJUVANT TO BUPIVACAINE FOR CAUDAL ANALGESIA IN CHILDREN UNDERGOING INFRA-UMBILICAL SURGERIES - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111673

Enrollment

Registered

2026-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Dexmedetomidine as adjuvant to Bupivacaine for caudal analgesia: Caudal bupivacaine 0.25 percent at 1 ml per kg with dexmedetomidine 1 mcg per kg. Total volume standardized to 1.1 ml pe

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 10 months and 8 years 2.ASA Grade I or II 3.scheduled for elective infra-umbilical surgery

Exclusion criteria

Exclusion criteria: 1.Emergency surgical conditions 2.Parental/gaurdian refusal for participation 3.Infection at caudal injection site 4.Known hypersensitivity to study drugs 5.Coagulopathy or bleeding disorders 6.Conginital spinal deformitiesor neurological disorder 7.Cardiopulmonary,renal or hepatic dysfunctions 8.Devepmental delay or mental retardation

Design outcomes

Primary

Measure	Time frame
1.Duration of postoperative analgesia (time to first rescue analgesia in minutes)Timepoint: 1.Duration of postoperative analgesia (time to first rescue analgesia in minutes)	—

Secondary

Measure	Time frame
1.Postoperative pain score (FLACC score) 2.Sedation score (Ramsay Sedation Scale) 3.Hemodynamic parameters (HR, SBP, DBP, MAP) 4.Incidence of adverse effects (nausea, vomiting, bradycardia, hypotension, respiratory depression)Timepoint: 1.15 min intervals for 1 hour, hourly for 6 hours, then 4 hourly till 24 hours 2.Postoperative period up to 24 hours 3.Intraoperative and postoperative up to 24 hours 4.Intraoperative and postoperative up to 24 hours	—

Measure

Time frame

1.Postoperative pain score (FLACC score) 2.Sedation score (Ramsay Sedation Scale) 3.Hemodynamic parameters (HR, SBP, DBP, MAP) 4.Incidence of adverse effects (nausea, vomiting, bradycardia, hypotension, respiratory depression)Timepoint: 1.15 min intervals for 1 hour, hourly for 6 hours, then 4 hourly till 24 hours 2.Postoperative period up to 24 hours 3.Intraoperative and postoperative up to 24 hours 4.Intraoperative and postoperative up to 24 hours

—

Countries

India

Contacts

Public ContactGaurav

Lala Lajpat Rai Memorial Medical College

ravi.agrawalravi@gmail.com9520531558

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026