Swaddle and/or sucrose role in the pain control during eye examinatio
Phase 3
- Conditions
- Retinopathy of prematurity.Retinopathy of prematurity
- Registration Number
- IRCT2014122610279N5
- Lead Sponsor
- Health Ministry Drug and Pharmacy General Management
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
Inclusion criteria; 1. Premature neonates who underwent first retinopathy of prematurity examination. Exclusion criteria; 1. Invasive or noninvasive mechanical ventilation therapy during retinopathy of prematurity examination. 2. Neonates who take analgesia, sedative medicine. 3. Asphyxia 4. Intraventricular hemorrhage 5. Neonates who were resuscitated 6. Neonates who had congenital anomaly
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Premature infant pain scale (PIPP). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.
- Secondary Outcome Measures
Name Time Method Crying time. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Desaturation (<85% for 10 seconds). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Frequency of bradycardia (<100 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Frequency of tachycardia (>180 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Degree of cry. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.