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Pain Reduction at Venipuncture in Newborns: Oral Glucose Compared With Local Anesthetic Cream

Maria Gradin, RN BSN^*, Mats Eriksson, RN, BSN^*, Gunilla Holmqvist, RN, BSN, Åsa Holstein, RN and Jens Schollin, MD, PhD^*

^* Department of Pediatrics, Örebro University Hospital, Örebro
Department of Pediatrics, Karolinska Institutet, Huddinge Hospital

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	ABSTRACT

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSION REFERENCES

 
Objective. A number of studies have shown that orally administered sweet-tasting solutions reduce signs of pain during painful procedures. The local anesthetic cream EMLA has recently been shown to be safe for use in neonates. This study compared the pain-reducing effect of orally administered glucose with that of EMLA cream during venipuncture in newborns.

Methods. Randomized, controlled, double-blind study including 201 newborns undergoing venipuncture for clinical purposes. Ninety-nine of the newborns received EMLA on the skin and orally administered placebo (sterile water), and 102 received glucose 30% orally and placebo (Unguentum Merck) on the skin. Symptoms associated with pain at venipuncture were measured with the Premature Infant Pain Profile (PIPP) scale (also validated for full-term infants). Heart rate and crying time were recorded.

Results. There were no differences in background variables between the 2 groups.

The results shows that the PIPP scores were significantly lower in the glucose group (mean: 4.6) compared with the EMLA group (mean: 5.7). The duration of crying in the first 3 minutes was significantly lower in the glucose group (median: 1 second) than in the EMLA group (median: 18 seconds). There were significantly fewer patients in the glucose group who were scored having pain (defined as PIPP score above 6); 19.3% compared with 41.7% in the EMLA group. The changes in heart rate were similar in both groups.

Conclusions. We found that glucose is effective in reducing symptoms associated with pain from venipuncture in newborns and seems to be better than the local anesthetic cream EMLA.

Key Words: newborn • pain • PIPP • glucose • EMLA

Abbreviations: PIPP, Premature Infant Pain Profile • SD, standard deviation

	INTRODUCTION

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Some painful, invasive procedures are necessary for care, and are commonly performed, in both healthy and sick neonates. Current evidence^1,2 shows that the newborn infant has both physiologic and anatomic capacity to experience pain. Recent research^3,4 suggests that pain experienced in the neonatal period might have long-term effects later in life.

Venipuncture is the recommended method for blood sampling in full-term neonates.⁵ Its advantages include an increased sample volume, greater efficacy, and less pain compared with heel stick.^6–8 An optimal blood sampling technique might play some part in pain reduction, but an effective analgesic method that is easy to use during the venipuncture procedure also contributes to relieving the infant’s distress.

A number of studies^9–11 have shown that orally administered sweet-tasting solutions reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a preabsorptive mechanism related to the sweet taste.^12,13

EMLA (Astra, Stockholm, Sweden), a local anesthetic cream, has proved to be an effective surface anesthetic skin agent in children and infants.¹⁴ Studies^15,16 have shown EMLA to be safe for use also in neonates, and this anesthetic cream is now recommended for full-term newborns in Sweden.

Studies of the effectiveness of EMLA-induced pain relief at venipuncture in newborns have led to different conclusions. Larsson et al¹⁷ and Lindh et al¹⁸ found that EMLA reduced signs of pain caused by venipuncture in healthy newborns, but Acharya et al¹⁹ did not observe any behavioral or physiologic differences between healthy preterms treated with EMLA and those given placebo.

Measuring pain in newborns is a complex problem. There has been extensive use of different physiologic and behavioral indicators. Current knowledge speaks in favor of using composite scales including both physiologic and behavioral measures.²⁰ One of the most frequently applied methods is the Premature Infant Pain Profile (PIPP). The PIPP was developed to assess acute pain in preterm and full-term newborns.²¹ Other signs of distress, such as crying and heart rate, are also used as pain indicators.²⁰

When newborns are treated in the neonatal intensive care unit, acute blood samples often are needed as part of the care. The application time for EMLA cream is 60 minutes, whereas oral glucose has an immediate effect. EMLA therefore is of limited use in the acute situation. The aim of this study was to compare the pain-reducing effect of orally administered glucose with that of EMLA cream during venipuncture in newborns.

	METHODS

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Participants
During a 21-month period (January 1999–October 2000), 201 neonates from the neonatal intensive care units and maternity wards of 2 Swedish hospitals (Örebro Medical Centre Hospital and University Hospital of Huddinge) were enrolled in the study.

Eligibility criteria were a gestational age of 36 weeks or more and a postnatal age >24 hours but <30 days at entry of the study. The exclusion criteria were assisted ventilation or continuous positive airway pressure treatment, neurologic symptoms, oxygen treatment, treatment for infection, and sedative or analgesia received within 24 hours before inclusion. Data from an earlier study⁸ was used to estimate the sample size with 80% power and P < .1. We hypothesized a difference in PIPP score of 1 and a standard deviation (SD) of 3.5. On inclusion in the study, the infants were randomly allocated to 1 of 2 groups by use of a table of random numbers. One of the 2 groups was given EMLA on the skin and placebo (sterile water) orally, and the other group received glucose 30% (Kabi Pharmacia, Stockholm, Sweden) orally and placebo (Unguentum Merck, Hermal, Reinbeck, Germany) on the skin. Treatments were received in identical packages marked only with a number. The Pharmacy of Örebro Medical Centre Hospital, Sweden performed the packing and randomization procedure in batches of 20. Ninety-nine infants were allocated to the EMLA group and 102 to the glucose group. The local Ethical Committee and the Swedish Medical Product Agency approved the study, and informed parental consent was obtained before inclusion.

Procedure
The study was controlled, randomized, and double-blind. All blood sampling in the study was performed for clinical purposes. One assistant nurse placed 0.5 g of EMLA or placebo on the dorsal aspect of the hand and covered it with an occlusive dressing (Tegaderm, 3M Sweden). After 60 minutes, the dressing and the test substance were removed. After waiting for another 15 minutes to reduce any constriction of the vein and any stress associated with removal of the dressing, blood sampling was performed. The infant was placed on a preheated nursing table, a pulse oximeter (Hewlett Packard, Palo Alto, CA, and Criticare 504, Criticare Systems Inc, Waukesha, WI, with average time periods of 10 and 21 seconds, respectively) was taped to the infant’s foot and the observer recorded the baseline oxygenation and heart rate. A 1 mL dose of 30% glucose or water was given by syringe into the infant’s mouth. The dosage was chosen with regard to previous studies.^8,9 The assistant nurse squeezed the newborn’s hand gently with the fingers or with a soft bandage to visualize the vein and then cleaned the skin with a local disinfectant. A staff member or the parents stood by the infant’s head and were encouraged to pacify the infant by giving it a pacifier or their own finger to suck on. To access the vein, a 21-gauge needle (Terumo, Leuven, Belgium) was used. After the blood was collected, an adhesive bandage was applied and the infant was left undisturbed on the nursing table for 3 minutes. Every child could be included only once.

Measurements
Pain response was measured by the duration of crying after the skin puncture and by the PIPP. The PIPP assigns points for changes in 5 parameters during the first 30 seconds after a painful event: 3 for different facial actions (brow bulge, eye squeeze, nasolabial furrow), 1 for heart rate, and 1 for oxygen saturation.²¹ The higher the score, the greater the pain response. Extra points are scored for behavioral states and gestational age. Generally, a total score of 6 or less indicates minimal or no pain. The infants in this study could reach a maximum PIPP score of 18. Changes in heart rate were also measured separately on 4 occasions: before the test, as the highest value during the first 30 seconds of the test, immediately after the blood sampling, and 3 minutes after the blood sampling was finished.

Four independent observers, trained in the PIPP method and familiar with the observation protocol (2 in Örebro, 2 in Huddinge), made the observations. Interobserver reliability was 0.81% using the intraclass correlation coefficient (Shrout-Fleiss reliability: fixed set).²²

Recordings were made of the total time taken for blood sampling, any local effect of the cream on the skin, the success of puncture of the vein, the time since last feed, use of a pacifier, and whether a parent was present, gently holding the infant’s hand. Other data, such as birth weight, sex, gestational age, Apgar score, and number of earlier invasive procedures such as heel stick and venipuncture, were collected from the infant’s medical records.

If data from any outcome variable were missing for a particular measurement, the case was excluded from that particular analysis but was included in any analyses that did not involve the missing variable.

The Student t test was used to assess difference in heart rate changes and the Mann-Whitney U test to assess difference in crying time. The Student t test, the Mann-Whitney U test, and the ² test were used for the PIPP score when appropriate. The ² test for independence was used for other categorical data. P < .05 was considered significant.

	RESULTS

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There were no significant differences between the groups in background variables (Table 1). Five infants were excluded after randomization, 1 in the EMLA group and 4 in the glucose group: 2 of them were <36 weeks, 1 infant had antibiotic treatment, 1 developed seizures during the procedure, and in 1 case the parents did not want to proceed.

View larger version (11K): [in this window] [in a new window]   Fig 1. Boxplot showing premature infant pain profile scores for infants in the EMLA and oral glucose groups undergoing venipuncture.

View larger version (8K): [in this window] [in a new window]   Fig 2. Kaplan-Meier curves representing the probability that the infants in the EMLA and glucose groups would become quiet at different time points.

Experience of previous invasive procedures was 43 infants having more than 3 earlier procedures in the EMLA group and 49 in the glucose group. A total of 49 parents were present during the study in the EMLA group and 44 in the glucose group. There were no significant differences between the 2 groups. There was a difference in the number of infants sucking during the procedure: 43 were sucking in the EMLA group and 56 in the glucose group (P = .027).

The frequency of successful sampling, measured as obtaining blood in the needle, was 74 in the EMLA group and 77 in the glucose group. The time needed for successful completion of the procedure was 161 seconds in the EMLA group and 169 seconds in the glucose group. There were no significant differences between the 2 groups.

The only local skin change that was considered to be possibly caused by the application of the cream on the hand was a small blush in 1 child in the EMLA group.

	DISCUSSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSION REFERENCES

 
This study supports the previously observed effectiveness of oral glucose in reducing symptoms associated with pain at venipuncture in newborns. Glucose seems to be better than the local anesthetic skin cream EMLA in this respect. The lower PIPP scores and the shorter crying time speak in favor of oral glucose. It is worth noting that only 20% of patients in the glucose group showed a PIPP score that indicates pain, compared with more than 40% in the EMLA group.

EMLA has been used for older children at venipuncture with good results,¹⁴ but studies in newborns are not conclusive.^17–19 Differences in study design and degree of prematurity might explain this difference, and the somewhat different effect compared with older children has been suggested to depend on differences in absorption from the skin and a high skin perfusion in the newborn. This has led to the suggestion that EMLA should be applied for a shorter time in newborns when used for heel sticks, which might also be true for other parts of the body.²³

Oral glucose is also advantageous in that only a short time is needed between giving the substance and performing blood sampling, whereas with EMLA it is necessary to wait, which means loss of time in an acute situation. The use of EMLA also limits the number of attempts at venipuncture that can be made, and repeated doses also increase the risk of methemoglobinemia. Furthermore, the loosening of the occlusive tapes might cause discomfort in the child when EMLA is used. A combined use of EMLA and glucose might be ideal and have an additive effect on pain.

We used a single oral dose of 1 mL of 30% glucose, which is well-tolerated by full-term newborns.⁸ Repeated smaller doses of sucrose might have an even better effect in premature infants¹¹ and should be studied for full-term newborns. There are no reported side effects when sweet tasting solutions are used for single procedures in newborns, but questions remain about the effect of multiple doses on glucose homeostasis and habituation to sweet-tasting solutions. The need for additional studies is therefore obvious.

The parents were instructed to encourage the infant to suck on a pacifier, a finger, or a hand during the venipuncture. More infants in the glucose group than those in the EMLA group sucked. This might be because the sweet solution stimulated sucking. Carbajal et al²⁴ showed that nonnutritive sucking combined with sucrose effectively reduces symptoms associated with pain, which favors the idea of an additive effect. The shorter duration of crying and the lower PIPP score in the glucose group might be explained by more children sucking in this group. However, 50% in each group did not suck, indicating that this is not the sole factor leading to pain symptom reduction. It seems beneficial to encourage the newborn to suck on something during venipuncture.

The question of how to measure pain in newborns is not easily answered, and various scales have been used. Crying is perhaps the most obvious pain behavior in neonates and has face validity as a measure of pain in infancy. The presence or absence of crying and crying time have been used in studies.^25,26 However, crying is of limited value as a single measure in preterm and ill neonates, who may not cry because of depleted energy reserves, or in intubated infants.²⁰

The increase of heart rate indicates sympathetic nervous system activity. Heart rate increase has been reported during painful events.^20,26 However, changes in heart rate alone do not determine the effects of interventions and are difficult to interpret because they also can be a consequence of other, nonpainful events. In combination with behavioral indicators, heart rate may add information about acute pain in neonates. Recent knowledge²⁰ favors the use of composite scales including both physiologic and behavioral measures. The PIPP scale fulfills this need, and it is easy and fast to use. It has had extensive reliability and validity testing under controlled research conditions and has also good validity and reliability for clinical settings.^20,27

	CONCLUSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSION REFERENCES

 
Our study supports the use of oral glucose in preference to EMLA at venipuncture in full-term newborns. Why glucose works better than EMLA is open to speculation. The fast absorption of EMLA and the high blood perfusion in neonates may be one explanation. Another explanation might be the activation of the endorphins by oral glucose, inducing a more central analgesic effect compared with EMLA’s acting only locally on the skin. Glucose is easy to use in acute situations, is effective and simple to use, and is well-tolerated by the newborn infants.

	ACKNOWLEDGMENTS

 
This study was supported by grants from the Research Committee of Örebro County Council, from the Örebro Medical Center Research Foundation, and from the Sven Johansson Memorial Foundation.

	FOOTNOTES

 
Received for publication Nov 19, 2001; Accepted Jun 20, 2002.

Reprint requests to (M.G.) Department of Pediatrics, Örebro University Hospital, S-701 85 Örebro, Sweden. E-mail: maria-gradin{at}telia.com

	REFERENCES

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION CONCLUSION REFERENCES

 

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