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Intranasal dexmedetomidine and oral sucrose for pain relief during eye examination for retinopathy of prematurity in preterm infants, a double-blinded randomized controlled trial.

Intranasal dexmedetomidine and oral sucrose for pain relief during eye examination for retinopathy of prematurity in preterm infants, a double-blinded randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240503003
Enrollment
46
Registered
2024-05-03
Start date
2024-05-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Intranasal dexmedetomidine and oral sucrose for pain relief during eye examination for retinopathy of prematurity in preterm infants retinopathy of prematurity, dexmedetomidine, oral sucrose, pain in neonate, PIP-R score

Interventions

oral 24% sucrose and intranasal dexmedetomidine 3 mcg/kg before eye examination,oral 24% sucrose and intranasal normal saline before eye examination
Experimental Drug,Placebo Comparator Drug

Sponsors

Research department, Faculty of medicine, Siriraj hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age (GA) less than or equal to 33 weeks or birthweight less than or equal to 1500 grams were candidates for eye examination according to ROP screening protocol in Siriraj hospital.

Exclusion criteria

Exclusion criteria: 1. Consent has not been obtained from the parents or legal guardians. 2. The parents are foreign nationals who cannot understand Thai language communication. 3. The infant is under continuous pain control medication and sedation via intravenous route. 4. The infant has congenital facial deformities, such as congenital ptosis or facial palsy. 5. The infant has cyanotic heart disease or irregular heart rhythm conditions present at birth. 6. The infants has brain abnormalities, including hydrocephalus or hypoxic ischemic encephalopathy (HIE). 7. The infant has hypertension (systolic blood pressure or diastolic blood pressure greater than the 95th percentile). 8. The weight at the time of ROP screening is less than 500 grams (may not be able to receive oral sucrose). 9. The infant has been diagnosed with an inborn error of fructose metabolism.

Design outcomes

Primary

MeasureTime frame
Pain score during ROP examination 30 sec post speculum insertion, during eye exam and 30 sec after eye exam PIPP-R score/ompared using either a t-test or a Mann-Whitney test, depending on the appropriateness of the data distribution.

Secondary

MeasureTime frame
Duration of Eye Examination The process of eye examination starts with inserting an eye speculum and ends with removing it second/ compared using either a t-test or a Mann-Whitney test, depending on the appropriateness of the data distribution.,side effect of intranasal dexmedetomidine during eye examination to within 24 hours after eye examination percentage of hypotension, bradycardia, apnea episode were compared between two groups using the Chi squared test,Convenience in ophthalmic examination by ophthalmologists after performing procedures, assessed for satisfaction after eye examination rated on a scale from 0 to 10 points

Countries

Thailand

Contacts

Public ContactBuranee Yangthara

Faculty of Medicine Siriraj Hospital, Mahidol university

buraneeyangthara@gmail.com0843270809

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026