Abstract
Background/Objective: The role of sucrose and/or non-nutritive sucking (NNS) has been evaluated for relieving procedural pain in newborn infants with satisfactory results however there was a controversy regarding the synergestic effect of their combination. Methods: This quasi – experimental study was conducted in the neonatal intensive care unit in Assiut University Children Hospital including 120 preterm neonates who were divided into 4 groups (20 neonates each). Control group received routine hospital care; sucrose group received oral sucrose solution (OS); pacifier group receive pacifier; and last group received oral sucrose solution and pacifier during painful procedures. All were assessed regarding socio-demographic and clinical data in addition to application of Premature Infant Pain Profile (PIPP) scale to assess the levels of pain and mean pain scores pre and post- intervention. Results: The 4 groups were similar regarding soci-demographic and clinical data. the application of the OS and/or pacifier, led to significant improvement of the levels of pain and reduction of the mean score of pain among preterm neonates during painful procedures. In addition, combined pacifier and OS was superior to OS alone and comparable to pacifier alone regarding their effect on the reduction of pain level and mean score of pain. Conclusion: OS and pacifier are effective as pain reliever during painful procedures among preterm neonates. Combined OS and pacifier is superior to OS and pacifier alone.
Key words: Sucrose, pacifier, neonatal intensive care unit, preterm neonates, pain relief, painful procedures
1. Introduction:
The international association for the study of pain has defined pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage [1]. As neonates can’t express their pain verbally, the assessment of pain depend on the accompanying physiological and behavioural consequences which can be recognized by professionals of health care. When the pain in the neonates is not managed adequately, mortality and morbidity are increased in addition to the development of hyperalgesia that may have adverse effects on the development [2].
The neonates are more liable to the harmful effects of pain when compared to older children because of the immaturity of the nervous system which make the pain experience more enhanced and prolonged [3]. It is estimated that, in neonatal intensive care unit (NICU), neonates are subjected to more or less than 14 painful procedures mostly in the 1st day; the majority of them are venipuncture and heellance [4].
Considering the long lasting consequences of undertreated procedural pain among preterm neonates, it has been suggested that, adequate treatment of procedural pain among preterm neonates during the first week of life has a long term positive developmental impacts [5]. In addition, repeated exposure of the neonates to procedural pain early in their life is considered to be remembered and sensitivity to pain may continue into childhood or even lifetime [6].
The well documented analgesic effect of oral sucrose (OS) in preterm and term infants can be explained by the indirect evidence of endogenous opioid mediation where its activation by oral sucrose decreases nociception and processing of noxious information at the level of the dorsal horn [7]. This is supported by the finding that, the analgesic effect of oral sucrose is suppressed by naloxone adminstraion which is an opioid antagonist [8].
It is well known that, non nutritive sucking (NNS) is an innate intrauterine activity of the fetus that facilitates their adjustment and interaction to environment. Accordingly pacifier was investigated as a method for pain relief. Therefore, neonatal nurses considered pacifier as a first choice of pain relieving intervention among neonates. Pacifiers are in expensive, easy to use, have quick onset, short duration of action with no side effects [9].
In a study conducted by Andersen et al., (2007), they concluded that, procedural pain in neonates is not sufficiently managed and pharmacological and comfort measures are underutilized according to clinical staff in Norwegian NICU [3].
Due to the conflicting results regarding the synergistic effect of both OS and NNS in pain relief during painful procedures among neonates and scarcity of studies including the subject in our locality, we designed this study to clarify the situation regarding this point of interest.
Significance of the study:
The old concept that, preterm neonates have low feeling of pain explained by the immature central nervous system is canceled [10]. Actually they have normal pain feeling because all the neurological structures essential for nociception are developed by 24 weeks of intrauterine life [11]. In addition, repeated exposure to painful stimuli may affect infants’ physiological processes and lead to changes in pain sensitivity leading to low pain threshold and feeling of pain even when exposed to other care such as handling [12].
Unadequately treated procedural pain among pretem neonates may lead to several consequences as prolonged hyperglycaemia, decreased oxygen saturation, tachycardia, decreased pain threshold and long term effects as cognitive deficits, learning disorder, poor motor performance and attention deficits [10].
Parents often rely on nurses to protect their infants from unnecessary pain experience considering nurses as the one who safeguard their preterm neonates. So nurses have the responsibility to act as pain advocates and promote the well-being of neonates [13].
The investigator when working as a staff nurse in a paediatric hospital has experienced that, the neonates exposed to painful procedures are often neglected and managed without any intervention. This has motivated the investigator to conduct this study so as to find out the effectiveness of OS and/or pacifier in pain management among them.
Aim of the study: to evaluate the efficacy of oral sucrose, pacifier and their combination on pain relive among preterm during painful procedures.
2. Materials and Method:
2.1. Research design: A quasi – experimental research design was used to conduct this study.
2.2. Setting: This study was conducted in the NICU at Assiut University Children Hospital.
2.3. Subjects: the study included a convenient sample of 120 preterm neonates who were selected from the previous setting. They were randomly divided into four groups: control group: included 30 preterm neonates who received routine hospital care; sucrose group: included 30 preterm neonates who received oral sucrose solution prior to painful procedures; pacifier group: included 30 preterm neonates who received NNS (pacifier) prior to painful procedures; pacifier and sucrose group: included 30 preterm neonates who received pacifier and oral sucrose solution prior to painful procedures.
2.3.1. Inclusion criteria: this study included preterm infants of both sexes who were hospitalized in NICU with gestational age less than 37 weeks and were subjected to painful procedure such as heellances.
2.3.2. Exclusion criteria: preterm infants with severe medical problems or surgical congenital anomalies, those taking nothing by mouth for any reason, those with hyperglycemia and those who received analgesia or sedation within 12 hours prior to data collection were excluded from the study sample.
2.4. Tools of the study: this study include two tools:
Tool I: Assessment sheet of preterm neonates: The researchers designed this sheet after reviewing the relevant literatures and consisted of: demographic and clinical data of preterm neonates such as gestational age, birth weight, current weight, gender, postnatal age, type of delivery and medical history. The validity of the questionnaire sheet was tested by 5 experts in the pediatric field where its value was 0.93 and the needed modifications were done accordingly. Cronbach's alpha test was used to evaluate the reliability of questionnaire sheet and found to be 0.86.
Tool II: Premature Infant Pain Profile (PIPP) scale. It was developed by Stevens et al. (1996) to assess preterm neonates pain profile. It consisted of 7 indicators: 3 behavioral indicators of facial actions: brow bulge, eye squeeze and naso-labial furrow, 2 physiologic indicators: heart rate and oxygen saturation and 2 contextual indicators: gestational age and behavioral state of infant pain. It included four point composite pain scales: 0,1,2,3. Scoring system is graded as follows: 0= no pain; 7=mild pain; 14 = moderate pain and 21= worst pain [14]. Reliability of tool II was assessed in previous study done by Elserafy et al., (2009) and its value was found to be 0.97 [8].
2.5. Method of data collection: Official Permission was obtained from the director of the Neonatal Intensive Care Unit in Assiut University Children Hospital. A pilot study was carried out involving 12 children (10% of the subjects, 3 of each group) to test the feasibility and applicability of the tools. Necessary modifications were done and they were excluded from the sample. The pain was assessed using a validated composite pain measure. Pulse oximetry was used to measure the baseline heart rate and oxygen saturation of the infant. The gestational age of the infant was scored on a 4-point scale. A research assistant who was blind regarding treatment allocation and study hypotheses scored each facial action as present or absent for the first 30 seconds of the venipuncture and 20 seconds for intramuscular injection and heellances. After that, the infant was observed for 15 seconds for scoring of the behavioral state regarding active, awake, quite or sleep. For the physiologic state, the infant was observed for 30 seconds and the maximum increase in heart rate and the minimum decrease in oxygen saturation were recorded. The total PIPP scores were calculated for each procedure by summing the scores of the 7 indicators. The intraclass correlation coefficient was 0.97. The preterm neonates in the sucrose group were given 0.5 ml sucrose 24%, the tip of a 1ml syringe without the needle was placed in the infant mouth and the solution instilled with gentle movement of the syringe to stimulate sucking for 30 seconds, each treatment was given 2 minutes prior to the procedure and the primary outcome measure was the evaluation of pain induced by painful procedure. The preterm neonates in pacifier group were given non-nutritive sucking ( pacifier), standard nipple stuffed with gauze square for resistance, held in the infant's mouth for 2 minutes prior the procedure and kept gently in the infant's mouth throughout the procedure. A new pacifier was used for every neonate and they were allowed to continue sucking after sampling. The preterm neonates in pacifier and sucrose group were given pacifier dipped with the sucrose solutions into the infants’ mouth for 2 minutes prior the procedure. The procedural pain was assessed by the researcher immediately after painful procedures by using the PIPP scale.
2.5. Ethical Considerations:
The research proposal was approved from Ethical Committee in the Faculty of Nursing, Assiut University. An informed consent was obtained from parents of participating neonates after explaining the nature and purpose of the study. The parents had the right to refuse to participate or withdraw from the study without any rational any time. Both confidentiality and anonymity were assured.
2.6. Statistical analysis:
Date were collected, entered and analyzed using the Statistical Package of Social Sciences (SPSS) version 19 (SPSS Inc, Chicago IL, USA). Data were presented as number, percentage, mean, standard deviation (SD). Mann-Whitney-U test was used to compare quantitative variables between two groups and ANOVA test was used for comparison of more than 2 groups. Chi-square was used to compare between qualitative variables. A p-value of < 0.05 was considered statistically significant.