Protocol summary

Summary
Objectives; Comparing the effect of repeated low dose and unique high dose sucrose with placebo (distilled water) on the control of pain secondary to retinopathy of prematurity examination of premature neonates. Design; Placebo controlled, double-blinded, randomized study. Setting and conduct; Single center, in Istanbul, Turkey. Participants including major eligibility criteria; Premature neonates who underwent first retinopathy of prematurity examination, who did not have asphyxia, intraventricular hemorrhage, who were not resuscitated, who had congenital anomaly, who underwent invasive or noninvasive mechanical ventilation therapy during retinopathy of prematurity examination, and who take analgesia or sedative medicine. Intervention; Distilled water group, three repeated doses of 0.2 ml sucrose (24%) and single dose of 0.6 ml sucrose (24%) group. Main outcome measures: Primary outcome measure was the “Premature Infant Pain Profile” (PIPP), which includes assessment of facial expressions, heart rate, oxygen saturation and took behavioral state and gestational age into consideration. Secondary outcome measures were heart rate differences, desaturation, crying time and the degree of cry.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122610279N4
Registration date: 2015-01-26, 1393/11/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-26, 1393/11/06
Registrant information
Name
Ozge Serce Pehlevan
Name of organization / entity
Zeynep Kamil Maternity and Children Education and Training Hospital
Country
Turkey
Phone
08 60 193 612 0900
Email address
ozge.serce@marmara.edu.tr
Recruitment status
Recruitment complete
Funding source
None
Expected recruitment start date
2010-12-01, 1389/09/10
Expected recruitment end date
2011-08-31, 1390/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of repeated low dose and unique high dose sucrose with placebo (distilled water) on the control of pain secondary to retinopathy of prematurity examination of premature neonates
Public title
Sucrose role in the pain control during eye examination
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 28 days old to 2 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Neonates were divided by three group; group 1 (Placebo group): Neonates who were given 0.2 ml distilled water 2 minutes before, during, and after the procedure by 2 minutes interval (n= 21); group 2: Neonates who were given 0.2 ml 24% sucrose 2 minutes before, during, and after the procedure (n= 22); group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 21). Neonates were randomly assigned to one of three treatment groups, using a computer generated randomization programme. The packed colorless study solutions were provided by the pharmacy in sealed envelopes to the patient’s nurse 3 minutes before the examination. The nurse, ophthalmologist, and investigators and the parents were blinded to the group assignment. Tropicamide (0.5%) and fenilefrin HCL were dropped to the eyes 2 times (10 minute interval) 60 minutes before eye examination, and local anesthetic medicine (Proparacaine; Alcaine drop 0.5%) were dropped to the eyes 30 minutes before the examination. Each neonate was equipped with an oxisensor connected to a Nelcor pulse oximeter (Ovidien RMS).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy
Street address
No:5, 2176 Sok., Sögütözü Mah
City
Ankara
Postal code
06520
Approval date
2010-12-27, 1389/10/06
Ethics committee reference number
19216

Health conditions studied

1

Description of health condition studied
Retinopathy of prematurity
ICD-10 code
H35-1
ICD-10 code description
Retinopathy of prematurity

Primary outcomes

1

Description
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 outcomes

1

Description
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

2

Description
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

3

Description
Desaturation (<85% for 10 second)
Timepoint
30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination
Method of measurement
Video records

4

Description
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

5

Description
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

Intervention groups

1

Description
Group 1(Placebo group): Neonates who were given 0.2 ml distilled water 2 minutes before, during, and after the procedure by 2 minutes interval
Category
Placebo

2

Description
Group 2: Neonates who were given 0.2 ml 24% sucrose 2 minutes before, during, and after the procedure
Category
Other

3

Description
Group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zeynep Kamil Maternity and Children's Education and Training Hospital
Full name of responsible person
Guner Karatekin
Street address
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
City
Istanbul

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy
Full name of responsible person
Cem Razi
Street address
No:5, 2176. Sok., Söğütözü Mah.
City
Ankara
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zeynep Kamil Maternity and Children's Education and Training Hospital
Full name of responsible person
Derya Benzer
Position
Neonatologist
Other areas of specialty/work
Street address
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
City
Istanbul
Province
Uskudar
Postal code
34668
Phone
0090 216 391 06 80
Fax
0090 216 391 06 90
Email
dbenzer@yahoo.com
Web page address
www.zeynepkamil.gov.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zeynep Kamil Maternity and Children's Education and Training Hospital
Full name of responsible person
Guner Karatekin
Position
Associate Professor
Other areas of specialty/work
Street address
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
City
Istanbul
Province
Uskudar
Postal code
34668
Phone
0090 216 391 06 80
Fax
0090 216 391 06 90
Email
gunerkaratekin@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zeynep Kamil Maternity and Children's Education and Training Hospital
Full name of responsible person
Ozge Serce Pehlevan
Position
Neonatologist
Other areas of specialty/work
Street address
No:3-4, Dr. Burhanettin Ustünel Sok., Zeynep Kamil Mah.
City
Istanbul
Province
Uskudar
Postal code
34668
Phone
0090 216 391 06 80
Fax
0090 216 391 06 90
Email
ozge_serce@hotmail. com
Web page address
www.zeynepkamil.gov.tr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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