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EASE OF MAKING ARTIFICIAL EYE WITH AND WITHOUT CONSCIOUS SEDATION USING MIDAZOLAM : A PILOT STUDY

COMPLIANCE OF PEDIATRIC PATIENTS DURING OCULAR PROSTHESIS FABRICATION WITH AND WITHOUT MIDAZOLAM CONSCIOUS SEDATION : A PILOT RANDOMIZED CONTROL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051465
Enrollment
24
Registered
2023-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: C692- Malignant neoplasm of retina

Interventions

Intervention1: VERSED SEDATIVE: Dose calculated based on weight of patient (0.2-0.8mg/kg) Frequency - at each appointment of ocular prosthesis fabrication Route of administration - intranasal Interven

Sponsors

ANSHU BAID
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects aged 1-14 years of age Subjects with unilateral enucleation, evisceration or exenteration.

Exclusion criteria

Exclusion criteria: Subjects under the age of 1 year or body weight Subjects with any form of acute disease Subjects with respiratory or cardiac disease that affects daily life Subjects with neuromuscular diseases as myasthenia gravis Subjects with allergy to benzodiazepine Subjects with sleep apnoea. Subjects with liver dysfunction (dose adjustment may be necessary) Subjects with hepatic dysfunction (dose adjustment may be necessary) Subjects with porphyria

Design outcomes

Primary

MeasureTime frame
To evaluate prosthetic outcome & ease of fabrication of ocular prosthesis in pediatric subjects with and without conscious sedation.Timepoint: At each appointment when step of ocular prosthesis fabrication is done.

Secondary

MeasureTime frame
The primary outcome is ease of fabrication of prosthesis whereas secondary outcome is time taken during ocular prosthesis fabrication, use of physical restraints during prosthesis fabrication and comparison of above parameters based on age and gender. Timepoint: To fill the pre-validated questionnaire at each appointment of ocular prosthesis fabrication

Countries

India

Contacts

Public ContactANSHU BAID

KING GEORGES MEDICAL UNIVERSITY

deeksha.arya@gmail.com9044953797

Outcome results

None listed

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