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

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Investigate the Efficacy of Sucrose During Eye Examination

Treatments: Dietary Supplement: Oral sucrose solution; Dietary Supplement: Steril water

Study type: Interventional

Funder types: Other

Identifiers

NCT01811979

69/04.01.2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 day to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

-VLBW infants <32 weeks of gestational age

Exclusion criteria

• infants >32 weeks of gestational age
• neuromuscular abnormality
• major abnormality

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

oral sucrose solution

Active Comparator group

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

Treatment:

Dietary Supplement: Steril water

steril water

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Oral sucrose solution