| Registry | NCT01872871 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: triple, supportive care |
| Enrollment | 80 (Estimated) |
| Sponsor | Dr. Sami Ulus Children's Hospital (Other) |
| Conditions | Retinopathy of Prematurity |
| Interventions | Paracetamol, Topical anaesthetic drop with placebo (Drug) |
| Dates | start 2013-01-01, primary completion 2013-08-01 (estimated), completion 2014-01-01 (estimated), first posted 2013-06-07, last updated 2013-06-07 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Retinopathy of Prematurity All trials of Paracetamol All trials of Topical anaesthetic drop with placebo
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| local anasthetic drops | Placebo comparator | Drug: Topical anaesthetic drop with placebo | topical anaesthetic drop with placebo |
| Paracetamol | Active comparator | Drug: Paracetamol | Topical anaesthetic drop with Paracetamol |
Sex: All, ages: any to 3 Months
Inclusion Criteria: * gestational age below 32 weeks or birth weight below 1500 grams Exclusion Criteria: * congenital anomalies, necrotising enterocolitis, surgical problems
| Facility | City | Country | Status |
|---|---|---|---|
| Dr. Sami Ulus Childrens Hospital | Ankara | Turkey (Türkiye) | Recruiting |