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A STUDY COMPARING TWO DRUGS, TRAMADOL AND FENTANYL AS ADJUVANTS WITH 0.25 PERCENT ROPIVACAINE FOR CAUDAL BLOCK IN PAEDIATRIC INFRAUMBILICAL SURGERIES

COMPARISON OF TRAMADOL VERSUS FENTANYL WITH 0.25 PERCENT ROPIVACAINE AS ADJUVANTS FOR CAUDAL BLOCK IN PAEDIATRIC INFRAUMBILICAL SURGERIES, A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107262
Enrollment
80
Registered
2026-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Interventions

Intervention1: CAUDAL BLOCK: To compare the analgesic efficacy, onset and duration of Tramadol (2mg/kg) versus Fentanyl (0.5mcg/kg) with 0.25% Ropivacaine as adjuvants for caudal block in pediatric in

Sponsors

Pacific Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient belonging to ASA physical status class I or II. Patient age 1 to 5 years. Patient weighing 5 to 15 kgs. Patient of both sexes.

Exclusion criteria

Exclusion criteria: Patients whose guardians refused to give consent. Patients having infection at puncture site. Patients having neurological disorder, history of developmental delay and bleeding diathesis. Patients having history of hypersensitivity to Local anesthetics . Patients having sacral or vertebral abnormalities, spina bifida or spine deformity.

Design outcomes

Primary

MeasureTime frame
The combination with better post operative analgesia effect and better hemodynamic profileTimepoint: SpO2, Heart rate ( HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure(MAP) to be monitored Pain will be assessed using FLACC scale post operatively 30 minutes, 60 minutes 90 minutes, 2hours, 4 hours , 6 hours , 10 hours, 12 hours. Total amount of rescue analgesia needed.—

Secondary

MeasureTime frame
Absence of side effects like bradycardia, vomiting, retching, urinary retention. Timepoint: To observe any side effects of the drug for 12 hours.—

Countries

India

Contacts

Public ContactDr Prakash Chandra Audichya

Pacific Medical College and Hospital

prakash.audichya10@gmail.com9929721889

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026