Swaddle and/or sucrose role in the pain control during eye examination

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014122610279N5
• Date of registration: 2015-02-24
• Prospective Registration: No
• Primary sponsor: Health Ministry Drug and Pharmacy General Management
• Public title: Swaddle and/or sucrose role in the pain control during eye examination
• Scientific title: Comparing the effect of swaddle and sucrose combination with unique effect of both swaddle, sucrose or placebo on the control of pain secondary to retinopathy of prematurity examination of premature neonates
• Date of first enrolment: 2010-12-01
• Target sample size: 83
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/10745
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, Other design features: Neonates were divided by four group; group 1(Placebo group): Neonates who were given distilled water 2 minutes before the procedure (n= 21); group 2: Neonates who were swaddled 15 minutes before the procedure (n= 20); group 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 22); group 4: Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure (n= 20). Neonates were randomly assigned to one of four 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 dropp
• Phase: 3

Countries of recruitment

Turkey

Contacts

• Name: Derya Benzer
• Affiliation: Zeynep Kamil Maternity and Children's Education and Training Hospital

• Name: Guner Karatekin
• Affiliation: Zeynep Kamil Maternity and Children's Education and Training Hospital

Key inclusion & exclusion criteria

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:

Age minimum: 28 days
Age maximum: 2 months
Gender: Both

Health Condition(s) or Problem(s) studied

Retinopathy of prematurity.
Retinopathy of prematurity

Retinopathy of prematurity

Intervention(s)

Intervention 1: Neonates who were given distilled water 2 minutes before the procedure. Intervention 2: Neonates who were swaddled 15 minutes before the procedure. Intervention 3: Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure. Intervention 4: Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure.

Neonates who were swaddled 15 minutes before the procedure

Placebo

Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure.

Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure.

Neonates who were given distilled water 2 minutes before the procedure

Primary Outcome(s)

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(s)

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.

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.

Source(s) of Monetary Support

Health Ministry Drug and Pharmacy General Management

Ethics review

Status: Approved
Approval date:
Contact:

Zeynep Kamil Maternity and Children's Education and Training Hospital Ethical Committee