Objective: A significant challenge for nurses who care for preterm infants in the neonatal intensive care unit is to provide effective pain relief during painful procedures. Nonnutritive sucking is commonly used as a comfort measure for infants. In addition, studies show that oral sucrose works effectively via opioid mechanisms to relieve neonatal pain. This study proposes to address the following research question: In the preterm infant, is there a difference between the effectiveness of a pacifier with repeated doses of 24% sucrose and a pacifier with repeated doses of sterile water to relieve pain associated with eye examinations performed to detect or monitor retinopathy of prematurity in preterm infants? In this ongoing study, pain is being measured with the Premature Infant Pain Profile (PIPP) (Stevens, 1996). The PIPP was designed to measure pain in preterm infants during therapeutic or diagnostic procedures. Researchers have used the PIPP to measure pain during various painful procedures, but it has not been used before to measure pain during eye examinations. Special problems are experienced during data collection because two measurements in the PIPP include observations of eye squeeze and brow bulge. Observation of facial expressions may be obstructed by the examiner’s hands, and only one eye can be observed at a time during the examination. Design: The study is a double-blind, randomized controlled trial. Preterm infants are randomly assigned to one of two treatments.
Population, Sample, Setting: The sample is made up of 80 preterm infants who are randomly assigned to one of two groups. These infants meet the criteria set by the institution for requiring eye examinations performed to detect or monitor retinopathy of prematurity. Criteria are as follows: a) weight of less than 1000 grams at birth, or b) weight between 1000 and 1500 grams and requiring oxygen for at least three days. The study is taking place in the NICU of an urban, university-affiliated medical center. Intervention and Outcome Variables: Preterm infants receive a pacifier and either (1) three doses of sterile water (0.1 ml per dose), or (2) three doses of 24% sucrose (0.1 ml per dose) during an eye examination. Treatment effectiveness is determined using the Premature Infant Pain Profile (PIPP) that records facial expressions, heart rate, and oxygen saturation, taking behavioral state and gestational age into consideration. These variables make up a composite pain score. A repeated measures ANOVA will be used to (1) analyze changes in pain scores by phase of treatment within treatment groups, and (2) determine if significant differences exist between the two treatment groups. Methods: Parents sign a consent form giving permission to include their infant in the study. Eye examinations are performed by a pediatric ophthalmologist according to the unit routine. Infants receive a pacifier and a dose of either sterile water or 24% sucrose two minutes before the eye examination. A second dose is administered at the start of the eye examination, and a third dose is administered two minutes later. A research assistant films facial expressions using a Sony camcorder, and the film is coded by an assistant who is blind to the procedure. Heart rate and oxygen saturation levels are measured with a Datex-Ohmeda 3740 oximeter that feeds data into a laptop computer. Physiologic data is recorded and organized using Satmaster software. Implications It is important for nurses to use behavioral measures to comfort the infant and to relieve pain. The long-term goal of this study is to develop guidelines for relieving pain in infants during diagnostic and therapeutic procedures. Specifically, the purpose of the study is to determine the effectiveness of oral sucrose and nonnutritive sucking for the relief of pain during eye examinations. The study may also give information concerning the feasibility of using the PIPP to measure pain during eye examinations.
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