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A clinical trial to study the effects of 3 different doses of dexmedetomidine on pain relief after surgery in children

A dose response study of caudal dexmedetomidine with ropivacaine in pediatric patients undergoing lower abdominal and perineal surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/03/003462
Enrollment
80
Registered
2013-03-08
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- post surgical pain

Interventions

Intervention1: Dexmedetomidine: dexmedetomidine 0.5 µg/kg, 1.0 µg/kg, and 1.5 µg/kg with ropivacaine 0.2% (0.75 ml/ kg) in caudal block before surgery Control Intervention1: placebo: only ropivacai

Sponsors

Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: eighty ASA physical status I-II children, aged 1 to 8 years, undergoing lower abdominal and perineal surgery

Exclusion criteria

Exclusion criteria: • Contraindication to caudal block (infection at site of block, bleeding diathesis, preexisting Neurological/ Spinal disease or abnormality of sacrum) • Children with conduction blocks. • History of allergic reaction to local anaesthetics or the study drugs. • History of developmental delay/mental retardation

Design outcomes

Primary

MeasureTime frame
postoperative analgesic duration and requirement of rescue analgesiaTimepoint: 24 hour postoperatively

Secondary

MeasureTime frame
Postoperative pain, nausea, vomiting sedation and agitationTimepoint: 24 hour postoperatively

Countries

India

Contacts

Public ContactRanganatha Praveen CS

Post Graduate Institute of Medical Education and Research

drrpcs@gmail.com9855746254

Outcome results

None listed

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