A study where two different amount of pain relief agents will be injected in the back and their effect on pressures inside the brain will be studied using ultrasound images in children less than two years

Comparison of Intracranial Pressure Changes (ONSD) and analgesic duration with two different volumes of caudal boluses in children less than two years: RCT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022026

Enrollment

240

Registered

2019-11-18

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: 4- Measurement and Monitoring

Interventions

Intervention1: 1.5 ml/kg Ropivacaine in caudal block: 1.5 ml/kg Ropivacaine is used instead of conventional dosage and increase in ICP and quality of analgesia is assessed Control Intervention1: 1 ml/

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children coming for infraumbilical surgeries 2. Children less than 2 years of age 3. ASA I & ASA II 4. Consenting for caudal block

Exclusion criteria

Exclusion criteria: 1. ASA III 2. Children with preexisting occular pathology 3. Children with preexisting cranial pathology 4. contraindications to caudal block 5. past anaphylaxis to ropivacaine

Design outcomes

Primary

Measure	Time frame
To evaluate difference in intracranial pressure at predefined intervals by measuring optic nerve sheath diameter using ultra sonogram after administration of two different volumes of caudal blockTimepoint: ONSD measured before the administration of caudal block, immediately after the administration and after 10 minutes, 30 minutes.	—

Secondary

Measure	Time frame
To assess the duration of analgesia with two different volumes of caudal block using FLACC scaleTimepoint: post operatively	—

Countries

India

Contacts

Public ContactMEERA G K

CHRISTIAN MEDICAL COLLEGE, VELLORE

drektarai@yahoo.com9789250113

Outcome results

None listed

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