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| ID | Type | Description | Link |
|---|---|---|---|
| B.10.4.Ä°SM.4.06.68.49 | Registry Identifier | Sami Ulus |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local anasthetic drops | Placebo Comparator | topical anaesthetic drop with placebo |
|
| Paracetamol | Active Comparator | Topical anaesthetic drop with Paracetamol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reducing pain assessment score | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serdar Beken | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sami Ulus Childrens Hospital | Recruiting | Ankara | 06080 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12682806 | Background | Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. doi: 10.1007/s00228-003-0585-3. Epub 2003 Apr 4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2014 | |
| Reset | Sep 4, 2014 | |
| Release | Sep 5, 2014 |
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| Topical anaesthetic drop with placebo | Drug |
|
| Reset | Sep 5, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2014 | Sep 4, 2014 | |||
| Sep 5, 2014 | Sep 5, 2014 |
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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