Intranasal dexmedetomidine and oral sucrose for pain relief during eye examination for retinopathy of prematurity in preterm infants, a double-blinded randomized controlled trial.
- Conditions
- Intranasal dexmedetomidine and oral sucrose for pain relief during eye examination for retinopathy of prematurity in preterm infantsretinopathy of prematurity, dexmedetomidine, oral sucrose, pain in neonate, PIP-R score
- Registration Number
- TCTR20240503003
- Lead Sponsor
- Research department, Faculty of medicine, Siriraj hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 46
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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