## Protocol Section
### Identification Module
**NCT ID:** NCT01811979

**Brief Title:** Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity

**Official Title:** Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination

#### Organization Study ID Info
**ID:** 69/04.01.2012
#### Organization
**Class:** OTHER
**Full Name:** Dr. Sami Ulus Children's Hospital
### Status Module
#### Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-05-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-05-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-04

**Type:** ACTUAL

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2013-05

#### Study First Post Date
**Date:** 2013-03-15
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-13
**Study First Submit QC Date:** 2013-03-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr. Sami Ulus Children's Hospital

#### Responsible Party

**Investigator Affiliation:** Dr. Sami Ulus Children's Hospital

**Investigator Full Name:** Dilek Dilli

**Investigator Title:** Assoc Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

**Detailed Description:** Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

### Conditions Module

**Conditions:**

- Investigate the Efficacy of Sucrose During Eye Examination

**Keywords:**

- eye examination, oral sucrose, premature infant pain scale

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** local anesthetic eye drops (Alcaine 0.5% drop) and a pacifier, plus 0.5 cc/kg of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity will be given

**Intervention Names:**

- Dietary Supplement: Steril water

**Label:** oral sucrose solution

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** steril water 0,5 cc/kg plus topical anesthetics (Alcaine %0.5 damla) before eye examination will be given

**Intervention Names:**

- Dietary Supplement: Oral sucrose solution

**Label:** steril water

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- steril water

**Description:** Oral sucrose solution plus topical anesthetics

**Name:** Oral sucrose solution

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- oral sucrose solution

**Description:** steril water plus topical anesthetics

**Name:** Steril water

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Premature Infant Pain Profile were determined after each eye examination

**Measure:** Premature Infant Pain Profile

**Time Frame:** two hours

#### Secondary Outcomes

**Description:** Crying time will be determined after each eye examination

**Measure:** Crying time

**Time Frame:** two hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

-VLBW infants \<32 weeks of gestational age

Exclusion Criteria:

* infants \>32 weeks of gestational age
* neuromuscular abnormality
* major abnormality

**Maximum Age:** 3 Months

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Dr Sami Ulus Children Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** MD

**Name:** Eda Ç İlarslan, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4.

**PMID:** 23440783

**Citation:** Dilli D, Ilarslan NE, Kabatas EU, Zenciroglu A, Simsek Y, Okumus N. Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatr. 2014 Feb;103(2):e76-9. doi: 10.1111/apa.12454. Epub 2013 Nov 11.

**PMID:** 24730361

#### See Also Links

**Label:** http://www.ncbi.nlm.nih.gov/pubmed/23440783

**URL:** http://www.ncbi.nlm.nih.gov/pubmed/23440783

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15013

- Name: Retinopathy of Prematurity

- Relevance: LOW

- As Found: Unknown

- ID: T4981

- Name: Retinopathy of Prematurity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M2340

- Name: Acetaminophen

- Relevance: LOW

- As Found: Unknown

- ID: M250773

- Name: Proxymetacaine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
