Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity

Ann Pharmacother. 2005 May;39(5):829-33. doi: 10.1345/aph.1E476. Epub 2005 Mar 29.


Background: Eye examinations for retinopathy of prematurity (ROP) are stressful and probably painful, but many ophthalmologists do not apply topical anesthetics because their efficacy in reducing pain has not been established.

Objective: To evaluate the potential benefits of topical anesthetic eye drops in reducing pain during neonatal eye examination for ROP.

Methods: Neonates born at < or =30 weeks' gestation and expected to have at least 2 examinations for ROP were included. Patients were randomly assigned to receive either proparacaine HCl ophthalmic solution 0.5% or NaCl 0.9% (saline) eye drops prior to an eye examination. In a subsequent examination, each patient received the alternate treatment. Eye drops were prepared in the pharmacy in identical tuberculin syringes, and physicians, nurses, and pharmacists were blinded to the treatment given. Pain was measured using a scoring system with both physical and physiologic measures of pain (Premature Infant Pain Profile [PIPP], possible range 1-21), which has been validated in preterm infants. PIPP scoring was performed simultaneously by 2 nurses: 1 and 5 minutes before and after the eye examination and during initial placement of the eye speculum. The same ophthalmologist performed all examinations.

Results: Twenty-two patients were studied, with 11 infants receiving proparacaine and 11 receiving saline as the first treatment. Crossover was performed with a median of 17.5 days between treatments. Patients experienced significantly less pain at speculum insertion with proparacaine than with saline (paired difference -2.5 +/- 3.4; p = 0.001).

Conclusions: Topical anesthetic pretreatment reduces the pain response to eye examination for ROP and should become routine practice. Because this is not effective in all infants, additional measures to reduce pain should be taken.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Anesthetics, Local*
  • Cross-Over Studies
  • Diagnostic Techniques, Ophthalmological
  • Double-Blind Method
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Intensive Care Units, Neonatal
  • Neonatal Screening
  • Pain / classification
  • Pain / drug therapy*
  • Pain Measurement / methods*
  • Propoxycaine*
  • Retinopathy of Prematurity / diagnosis*


  • Anesthetics, Local
  • proxymetacaine
  • Propoxycaine