Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water

Abstract

Objectives To compare the efficacy of orally administered 10% dextrose, breast milk and sterile water on pain prevention during screening examination for Retinopathy of prematurity (ROP) in preterm neonates as measured by Premature infant pain profile (PIPP). Methods A three-limbed double-blinded randomized control trial was conducted in a Level 3 neonatal intensive care unit. Forty five preterm neonates undergoing ROP screening were included. Eligible babies were randomly assigned to one of the three groups that orally received either expressed breast milk (n = 14), 10% dextrose solution (n = 14) or sterile water (n = 17), one minute before eye examination. The outcome measure was PIPP score. Results All 3 groups were similar in baseline characteristics. The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9). The behavioral and physiological variables were also similar across all three groups. Conclusions Expressed breast milk, 10% dextrose or sterile water administered orally before ROP screening in preterm neonates have similar analgesic effects and do not significantly alleviate pain during the procedure.

Nonpharmacological Applications During the Retinopathy of Prematurity Examination and Their Effects on Pain Control

“…Four studies described the random sequence generation process 12,14,18,20. Two studies provided information about allocation concealment 14,18.…”

“…Four studies described the random sequence generation process 12,14,18,20. Two studies provided information about allocation concealment 14,18. Lack of information on allocation concealment and randomization increases the risk of bias.…”

“…Methodological quality assessment of 6 studies according to the randomized controlled trial checklist of Joanna Briggs Institute ("+" = yes; "−" = no; "?" = unclear; and "x" = "not available") Items Sagheb et al 21 Nayak et al 14 Şener Taplak and Erdem 12 Rosali et al 18 Dilli et al 19 Costa et al 20 Item 1 (Nordic Cochrane Center, Copenhagen, Denmark). Heterogeneity between the studies was assessed with the Cochran Q test and Higgins I 2 , and an I 2 value of more than 50% was regarded as a heterogeneity indicator.…”

“…Nayak et al, 14 India n = 45 >1250 g <1250 g 32 1 min before the examination, the following were administered in each group: • Group 1: 10% dextrose (n = 14) • Group 2: Breast milk (n = 14) • Group 3: Dropped distilled water (n = 17) Assessments were performed 1 min before, during, and 1 min after the examination.…”

“…9 Nonpharmacological methods used as alternatives to pharmacological methods for pain reduction during ROP examination in recent evidence-based studies include the use of sucrose; sucrose with enveloping and nonnutritive absorption; sucrose and nonnutritive suction; breast milk, sucrose, and distilled water; and the Neonatal Individualized Developmental Care and Assessment Program during breastfeeding and retinopathy eye examinations. 1,2,[12][13][14] Preventing or minimizing the pain experienced during ROP examination is a natural right of every newborn and warrants a multidisciplinary approach. The pain experienced by premature infants should be assessed before, during, and after the ROP examination, and newborn-specific and family-centered developmental care should be provided.…”