To compare effectiveness of preservative free Ketamine and Fentanyl as an adjuvant to Bupivacaine in caudal block for postoperative analgesia in children undergoing sub umbilical surgeries

Effectiveness and safety of Ketamine and Fentanyl as an adjuvant to Bupivacaine for Caudal block in paediatric subumbilical surgeries - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063424

Enrollment

Registered

2024-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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: 3- Administration Health Condition 3: N43- Hydrocele and spermatocele

Interventions

Intervention1: Caudal epidural block with inj 0.25% Bupivacaine. One group of patients will receive preservative free ketamine and other group will receive inj Fentanyl: One group of patients will re

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex belonging to ASA I& II age between 2-6 years undergoing subumbilical surgeries

Exclusion criteria

Exclusion criteria: Patient and parent refusal ,Infection present at caudal site ,allergic to study drug ,Coexisting coagulopathy ,any neurological condition and failed block,Caudal vertebral anomalies

Design outcomes

Primary

Measure	Time frame
Duration of postoperative analgesia In children undergoing subumbilical surgeries which will be measured from administration of caudal block to time for first rescue analgesic.Timepoint: Duration of postoperative analgesia will be recorded by FLACC score(more than 4). It will be measured in hrs for first 24 hrs postoperatively	—

Secondary

Measure	Time frame
need of total rescue analgesics over 24 hours, Perioperative haemodynamic safety , Complications if anyTimepoint: number of rescue analgesics with in 24 hours,Intraop failure of block requiring Fentanyl	—

Countries

India

Contacts

Public ContactDr Pooja Fulchand Nirwan

Smt Kashibai Navale Medical College, Pune

kadate29@gmail.com9623440142

Outcome results

None listed

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