Comparison of fentanyl with ketodex for squint surgery in children

Comparison of opioid sparing protocol with Ketodex versus Fentanyl in Paediatric Strabismus Surgery:A Prospective Double Blind Randomised Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077508

Enrollment

Registered

2024-11-29

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: H509- Unspecified strabismus

Interventions

Intervention1: Ketamine and Dexmedetomidine: After inhalational induction, intravenouse Ketamine 1mg/kg once and after SGD insertion,intranasal Dexmedetomidine 1Ã?Âµg/kg Once Intervention2: Dexmed

Eligibility

Inclusion criteria

Inclusion criteria: ASA PS-1 or 2 posted for elective strabismus surgery

Exclusion criteria

Exclusion criteria: Parental refusal ASA 3 or 4 OSA Difficult airway History of motion Sickness Cardiac abnormality History of seizure disorder Intellectually disabled

Design outcomes

Primary

Measure	Time frame
To compare the perioperative analgesia with ketodex (ketamine +dexmedetomidine) vs fentanyl in paediatrics strabismus surgeryTimepoint: From start of surgery till 24 hours post-surgery	—

Secondary

Measure	Time frame
To compare the incidence of oculocardiac reflexTimepoint: From start of surgery to the end of surgery;To compare the incidence of emergence deliriumTimepoint: From extubation till 24 hours post surgery;To compare the incidence of PONVTimepoint: From extubation till 24 hours post surgery;To compare the postoperative recovery scoreTimepoint: From extubation to 2 hours after surgery;To compare surgeon satisfactionTimepoint: At the end of surgery;To compare parent satisfactionTimepoint: At the time of discharge	—

Measure

Time frame

To compare the incidence of oculocardiac reflexTimepoint: From start of surgery to the end of surgery;To compare the incidence of emergence deliriumTimepoint: From extubation till 24 hours post surgery;To compare the incidence of PONVTimepoint: From extubation till 24 hours post surgery;To compare the postoperative recovery scoreTimepoint: From extubation to 2 hours after surgery;To compare surgeon satisfactionTimepoint: At the end of surgery;To compare parent satisfactionTimepoint: At the time of discharge

—

Countries

India

Contacts

Public ContactTapeshwar Kumar

All India Institute of Medical Sciences ,New Delhi

renusinha@aiims.edu09810305156

Outcome results

None listed

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