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Dexmedetomidine in Caudal Block for Post-op Analgesia

â??A Comparative Evaluation of two doses of Dexmedetomidine as an Adjuvant to Ropivacaine for Caudal Analgesia in Pediatric Infraumbilical Surgeries: A Randomized Controlled Trialâ? - CEDAR-CP

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096121
Enrollment
90
Registered
2025-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: Ropivacaine with Dexmedetomidine: 1 mcg/kg dexmedetomidine will be added to 0.25% Ropivacaine 1ml/kg up to maximum of 15 ml in caudal anesthesia Intervention2: Ropivacaine with Dexmedet

Sponsors

Bhagat Phool Singh Gov Medical College for women KHANPUR KALAN SONIPAT
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA physical status I and II 2.Age between 1â??8 years 3.Elective infra-umbilical surgeries

Exclusion criteria

Exclusion criteria: 1.Refusal by parents guardian 2.Weight more than 30 kgs 3.History of allergy to local anesthetic drug 4.History of bleeding diathesis 5.Localized skin infection at the site of injection Preexisting neurological condition or spinal disease or malformation Cardiovascular respiratory renal hepatic or any other systemic disease

Design outcomes

Primary

MeasureTime frame
To compare the analgesic efficacy of caudal ropivacaine with or without dexmedetomidine among three groups in terms of time to first rescue analgesic dose and total analgesic requirements in 24 hours postoperativelyTimepoint: @ 30 min. 1, 2, 4, 6, 12 and 24 hrs.

Secondary

MeasureTime frame
To evaluate and compare the incidence and severity of emergence agitation using a validated agitation scale. Timepoint: @ 5, 10, 15 and 30 min. post-extubation;To evaluate and compare Safety profile, in terms of Sedation levels, Hemodynamic stability and adverse effects among the three groups.Timepoint: @ 30 min. 1, 2, 4, 6, 12 and 24 hrs.;To assess parental satisfaction among all the groups.Timepoint: @ 30 min. 1, 2, 4, 6, 12 and 24 hrs.

Countries

India

Contacts

Public ContactDR MEENA SINGH

GOV. MEDICAL COLLEGE

pranavbansal1@gmail.com8222007555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026