Use of oral glucose as analgesic for newborn babies undergoing eye examination

Effectiveness of Oral glucose as analgesic for neonates undergoing ROP screening - A randomised pilot study for a parallel randomised control trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013639

Enrollment

Registered

2018-05-03

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: null- Neonates undergoing first ROP Screening

Interventions

Intervention1: Oral Glucose Solution - 25% dextrose: 25% dextrose solution - 1ml/kg, given once orally 5 minute before procedure along with phenylephrine eye drops. Control Intervention1: Placebo: D

Eligibility

Inclusion criteria

Inclusion criteria: All babies satisfying the unit ROP screening protocol and undergoing the screening procedure for the first time, will be included after getting a written consent from parents / caretakers.

Exclusion criteria

Exclusion criteria: 1. Babies on mechanical ventilator 2. Babies already on study drugs for any other reason 3. Breastfeeding mother in methadone or other analgesics 4. Babies with ileostomy / colostomy. 5. Babies kept NPO for other medical / surgical illness 6. Congenital anomalies

Design outcomes

Primary

Measure	Time frame
(i) To assess Pain score by PIPP at 1 min post procedure (As planned for Phase III trial) (ii) recruitment and retention rates. (ii) Staff capacity to recruit and familiarity for randomisation procedures. (iii) availability of equipments and back up. (iv) estimate of effect size and use for sample size calculation for main study.Timepoint: (i) To assess Pain score by PIPP at 1 min post procedure (ii) recruitment and retention rates. (ii) Staff capacity to recruit and familiarity for randomisation procedures. (iii) availability of equipments and back up. (iv) estimate of effect size and use for sample size calculation for main study.	—

Measure

Time frame

(i) To assess Pain score by PIPP at 1 min post procedure (As planned for Phase III trial) (ii) recruitment and retention rates. (ii) Staff capacity to recruit and familiarity for randomisation procedures. (iii) availability of equipments and back up. (iv) estimate of effect size and use for sample size calculation for main study.Timepoint: (i) To assess Pain score by PIPP at 1 min post procedure (ii) recruitment and retention rates. (ii) Staff capacity to recruit and familiarity for randomisation procedures. (iii) availability of equipments and back up. (iv) estimate of effect size and use for sample size calculation for main study.

—

Secondary

Measure	Time frame
(i) Pain scores a â?? 5min after procedure - 15min after procedure. - 30 min post procedure (ii) Adverse events - will be recorded in both groups.Tachycardia 180/min, Apnea, Abdominal distention, feed intolerance, increase in respiratory support - increase in Fio2 increase by 20%, flow increase by 10%, increase in PEEP by 1 , requiring new respiratory support or mechanical ventilation for 24 hours.Timepoint: 5min, 15 min and 30 min post procedure and monitor for 24 hours for adverse events	—

Measure

Time frame

(i) Pain scores a â?? 5min after procedure - 15min after procedure. - 30 min post procedure (ii) Adverse events - will be recorded in both groups.Tachycardia 180/min, Apnea, Abdominal distention, feed intolerance, increase in respiratory support - increase in Fio2 increase by 20%, flow increase by 10%, increase in PEEP by 1 , requiring new respiratory support or mechanical ventilation for 24 hours.Timepoint: 5min, 15 min and 30 min post procedure and monitor for 24 hours for adverse events

—

Countries

India

Contacts

Public ContactPrakash

Madras Medical College

dr_praky76@yahoo.com9968857025

Outcome results

None listed

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