A clinic trial to study the analgesic effect of fentanyl as an adjuvant to ropivacaine in paediatric patients undergoing infraumbilical surgeries in general anaesthesia

A randomized controlled study for analgesic efficacy of fentanyl as an adjuvant to ropivacaine in caudal epidural block in paediatric patients undergoing infraumbilical surgeries in general anaesthesia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090057

Enrollment

Registered

2025-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: - Health Condition 2: N37- Urethral disorders in diseases classified elsewhere

Interventions

Intervention1: Caudal epidural block: analgesic efficacy of fentanyl as an adjuvant to ropivacaine in Caudal epidural block in pediatric patients undergoing infraumbilical surgeries in general anae

caudal epidural

Eligibility

Inclusion criteria

Inclusion criteria: 1. Paediatric Patients undergoing Infraumbilical surgeries in general anaesthesia. 2. Patients with written & informed parental consent/ assent (where able applicable). 3. Weight between 16kg to 25 kg 4. ASA grade I and II.

Exclusion criteria

Exclusion criteria: 1. Noncooperative patient. 2. Patient should not be part of other study. 3. History of hypersensitivity to study drugs. 4. Patients having bleeding/clotting diseases, local infection, sepsis deformity, pre existing neurological diseases.

Design outcomes

Primary

Measure	Time frame
1. To assess and compare time to first rescue analgesic requirement [duration of postoperative analgesia ] in both the groups . 2. To assess and compare the severity of pain using CHOPS score and RAMSAY score in both the group.Timepoint: WITHIN 24 HOURS	—

Secondary

Measure	Time frame
1.To assess and compare the changes in hemodynamic variables(SBP,DBP,MAP,HR,SpO2) in the intraoperative period in both groups within 24 hours. 2.To asses and compare the proportion of cases having side effects in both groupsTimepoint: WITHIN 24 HOURS	—

Countries

India

Contacts

Public ContactDr Rama chatterjee

S.M.S medical college and hospital jaipur

chatterjeerama30@gmail.com9828622026

Outcome results

None listed

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