Evaluation of the analgesic effect of oral sucrose solution on neonates undergoing a minor painful procedure

Kallol Paul; Pankaj Kumar Halder; Rituparna Das; Arpita Choudhury; Prerna Goenka; Sourav Roy

doi:10.4103/cjhr.cjhr_14_22

ORIGINAL ARTICLE

Year : 2022 | Volume : 9 | Issue : 4 | Page : 258-261

Evaluation of the analgesic effect of oral sucrose solution on neonates undergoing a minor painful procedure

Kallol Paul¹, Pankaj Kumar Halder², Rituparna Das³, Arpita Choudhury⁴, Prerna Goenka⁵, Sourav Roy²
¹ Department of Pediatric Medicine, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India
² Department of Pediatric Surgery, R G Kar Medical College, Kolkata, West Bengal, India
³ Department of Anesthesiology and Critical Care, ESIC Medical College and Hospital, Kolkata, West Bengal, India
⁴ Department of Anesthesiology, R G Kar Medical College, Kolkata, West Bengal, India
⁵ Department of Pediatric Medicine, SSKM and IPGMER, Kolkata, West Bengal, India

Date of Submission	08-Feb-2022
Date of Decision	19-Nov-2022
Date of Acceptance	25-Nov-2022
Date of Web Publication	17-Mar-2023

Correspondence Address:
Pankaj Kumar Halder
Saroda Pally, Baruipur, Kolkata - 700 144, West Bengal
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/cjhr.cjhr_14_22

Abstract

Background: Pacifying newborns by nonpharmacological methods during painful procedures is a frequent and difficult problem in routine practice. Purpose: The purpose of the study was to determine the analgesic effects of oral sucrose solution in comparison to placebo (sterile water) in neonates. Materials and Methods: A prospective, double-blinded study of 100 neonates who were divided into two groups after simple randomization, to give either 30% sucrose solution (group A) or sterile water (group B) during an intravenous catheterization. Assessment of pain by the Douleur Aigue Nouveau-ne scale (DAN) and changes in the heart rate (HR), respiratory rate (RR), or arterial oxygen saturation (SpO₂) during peripheral vein catheterization were analyzed. Results: The mean change of HR, RR, and SpO₂ was more in group B compared to group A. The mean DAN scores were 2.24 ± 2.026 and 6.92 ± 2.538 in group A and group B, respectively. None of these results were statistically significant (P > 0.05). Conclusion: There was a less prominent change in HR, RR, and SpO2 with response to noxious stimuli with oral sucrose administration in newborns when compared to placebo.

Keywords: Behavioral, effect, neonate, physiological, sucrose

How to cite this article:
Paul K, Halder PK, Das R, Choudhury A, Goenka P, Roy S. Evaluation of the analgesic effect of oral sucrose solution on neonates undergoing a minor painful procedure. CHRISMED J Health Res 2022;9:258-61

How to cite this URL:
Paul K, Halder PK, Das R, Choudhury A, Goenka P, Roy S. Evaluation of the analgesic effect of oral sucrose solution on neonates undergoing a minor painful procedure. CHRISMED J Health Res [serial online] 2022 [cited 2023 Apr 1];9:258-61. Available from: https://www.cjhr.org/text.asp?2022/9/4/258/371933

Introduction

The newborn may experience a greater magnitude of pain as the pain regulation is more or less ineffectual in newborns.^[1] Recent studies have reported that simple and benign interventions (oral sugar solutions, milk, and sucking a pacifier) can reduce pain in neonates during any painful procedure.^[2] The use of sucrose has been shown to be safe and has no serious or life-threatening secondary effects after a single dose.^[3] Intravenous catheterization (IVC) is the most commonly performed painful procedure in acutely ill neonates that evokes crying and analgesia in this age group is administered rarely. This study determines the effectiveness of oral sucrose solution for pain intervention in infants presenting to the newborn period who are younger than or equal to 28 days of age.

Materials and Methods

Between February 2012 and January 2015, a prospective study has been carried out with 100 newborns irrespective of sex, socioeconomic status, and birthplace. Ethical approval was obtained from the institution ethics committee (approval number-157 [01/31]) beforehand. We excluded the newborns with <32 weeks of gestational age, hyperglycemia, asphyxia, inability to suck or swallow, hereditary fructose intolerance, sedation or on other pain medications, associated congenital heart disease/esophageal atresia/tracheoesophageal fistula, or mother taking methadone, and postoperative patients who need to avoid excessive saliva production. In our study, observers got standardized training on the DAN scoring system and study protocol using video footage. All other personnel of the study team were kept completely unaware about the randomization tables as a research pharmacist conducted the randomization using a random numbers table.

Study design

It was a prospective, randomized, double-blinded study.

Techniques

Eligible neonates for whom the attending pediatrician determined that an IVC was required were enrolled by six posted nurses who had undergone prior training to participate in the study. The pain was assessed by the study nurses by using the previously validated DAN scale [Figure 1] xand any changes in the heart rate (HR), respiratory rate (RR), and Arterial oxygen saturation (SpO2) during an IVC.

Figure 1: DAN score

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Study procedure

The study drug or placebo (both were indistinguishable by color, smell, and viscosity) was preloaded into coded syringes by the pharmacy and was placed in a sealed package, stored in a fridge in an area to which only the nurses had access. After preparing the enrolled participants, but before sterile preparation and IVC, baseline DAN scores were recorded. Patients were then administered 2 ml of the study drug orally (either sterile water or 30% sucrose solution) after written consent from parents. The study nurse obtained the next labeled syringe which was recorded with the patient's data and on a separate list containing the patient's name, which was kept separate from the data. After a 2-min wait, the infant's peripheral vein was catheterized in standard sterile fashion by a pediatrician who was not responsible for the study observations. No other specific comfort measures were used as part of the study. Pacifiers were given to patients as per parental request. To minimize interobserver variation, DAN scores, and other parameters were recorded at the first prick. The time needed for the patient to return to behavioral baseline was recorded. If after 3 min, the infant had not returned to baseline, a new DAN score was assigned.

Statistical analysis

The data regarding the changes in the HR, RR, SpO2, and DAN scores were recorded. The statistical analysis was carried out using a statistical package for the social sciences (SPSS Inc., Chicago, USA) software version 20. Categorical variables were expressed in the cross table as the number (percentage) of patients in each nominal and ordinal category. Numeric parametric data were compared by unpaired t-test (independent sample t-test). Nominal and ordinal data were compared by Fischer's exact test. A P < 0.05 was considered statistically significant.

Results

In our study, the male–female ratio was 1:1.17. Eighty babies (80%) were born of normal vaginal delivery, fourteen (14%) were of the lower uterine cesarean section, and six (6%) were by breech delivery. Thirty-four (34%) babies were preterm (gestational age <37 completed weeks), 56 (56%) babies were term (gestational ages between 37 completed weeks and 42 completed weeks), and 10 (10%) babies were postterm (gestational ages >42 completed weeks). Instead of 10% having a normal birth weight (>2500 g), 90% of newborns had low birth weight.

The neonates were divided equally among two groups receiving oral sucrose solution and sterile water and were denoted as group A and group B, respectively. There was no significant variation in age, sex, birth weight, gestational age, or cause of hospitalization among the groups (P < 0.05). The study showed an increased mean of change in the HR, RR, and a declined SpO2 in group B than in group A [Table 1] and [Table 2]. A P value of 0.2381, 0.3658, and 0.1611 for the three groups, respectively, and were not statistically significant. Similarly, the mean DAN score was 2.24 ± 2.026 and 6.92 ± 2.538 in group A and group B, respectively, which means group B neonates perceived more pain than in group A (P > 0.05).

Table 1: The change in heart rate, respiratory rate, and oxygen saturation and Douleur Aigue du Nouveau-ne scale score along with minimum, maximum, mean values, and standard deviation in group A patients who received oral sucrose solution before intravenous catheterization (n=50)

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Table 2: The change in heart rate, respiratory rate, and oxygen saturation and Douleur Aigue du Nouveau-ne scale score along with minimum, maximum, mean values, and standard deviation in group B patients who received oral sterile water before intravenous catheterization (n=50)

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Discussion

Newborns have an immature descending neuronal pathway, resulting in a greater magnitude of pain (ineffective pain modulation) that lasts for a longer period of time and unfavorably affects clinical as well as behavioral parameters of their present and future.^[4] Prolonged stress may lead to permanent changes in brain processing, irreversible depletion of hippocampal dendrites, and have detrimental effects on the subsequent ability of the infant to learn and remember new information.^[5]

There are several validated pain scales for neonates such as (i) neonatal infant pain scale (ii) neonatal facial coding system, (iii) neonatal pain, agitation, and sedation scale, (iv) cry, required oxygen, increased vital signs, expression, sleeplessness scale, and (v) Douleur Aigue Nouveau-ne (DAN) scoring system.^[6] We used the DAN scale which evaluates (a) facial expression (0–4), (b) limb movements (0–3), and (c) and vocal expression (0–3). It grades the pain from 0 to 10, where 0 is no pain and 10 is maximum pain.^[7]

Several studies have used crying as the principal tool to assess pain, although closely related, it is not unique to pain.^[8] Raeside suggested a multidimensional (behavioral and physiological indicators) approach is important for the appropriate assessment of pain in neonates.^[9] In our study, we considered both behavioral changes (DAN scale) and physiological variables (HR, RR, and SpO2). Zempsky et al. said that a multifaceted perspective that includes anxiolysis, nursing-staff education, and the evolution of individualized pain management conventions may provide comfort to neonates in the emergency setting.^[10]

Pharmacologic pain management is the gold standard. Ekman and Koman recommended a combination of pharmacologic and nonpharmacologic approaches (multimodal therapy) during musculoskeletal surgery in infants and neonates.^[11] A conjunctive eutectic mixture of local anesthetics also provides better analgesia during neonatal circumcision.^[12] Erkut et al. recommended swaddling (a quick and simple nonpharmacologic method) as a complementary therapy for newborns during painful procedures.^[13] Kumari et al. showed 25% glucose and 24% sucrose can effectively reduce the pain during heel lance in preterm neonates.^[14] A solution of 12%–>50% of sucrose has been studied in neonates. We used 30% sucrose solution because it was easy to prepare by the pharmacist in our setup. Moreover, the dose of 2 ml was selected because it has been shown to be effective in full-term infants too. Gao et al. found limited evidence regarding the efficacy and safety of repeated sucrose for repeated procedural pain in neonates.^[15]

Our results showed an escalated HR, RR, and diminished SpO2 in group B patients. A lower DAN score (2.24) in group A compared to group B (6.92), with 95% confidence interval of 3.7686 and 5.5914, respectively, were also evident. However, these differences were not statistically significant. Like us, Gouin et al. did not find statistically significant results in pain scores, HR variations, as well as in crying time with administration of oral sweet solution before the painful procedure in neonates.^[16] Similarly, Desjardins et al. were uncertain about the efficacy of oral sweet solution to decreasing pain during bladder catheterization.^[17] We believe that multiple factors (pain assessment tools, techniques, type of painful procedure, and observer's bias) can influence a randomized, double-blinded study. We chose appropriately qualified nurses to record the DAN score and research pharmacists for randomization to reduce these biases.

Curtis et al. did a study for venipuncture in infants aged 0–3 months and concluded that oral sucrose appears to provide additional benefit in neonates when used with a pacifier.^[18] Similarly, Elserafy et al. proved the synergistic effect of the combination of sucrose and nonnutritive sucking on relieving the procedural pain in preterm and term neonates.^[19] We did not allow pacifiers routinely; however, a pacifier was given to patients as per parental request.

Conclusion

Although our results apparently showed a superior pain control in neonates with oral sucrose, however, these were not statistically significant. The use of multiple observers in our study potentially added scatter into the data but did not create a systematic bias that would skew the results toward a particular outcome. A larger study population with a randomized control group could yield stronger recommendatory results.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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