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. 2016 Jul 15;2016(7):CD001069. doi: 10.1002/14651858.CD001069.pub5

11. Trials assessing pain during multiple procedures.

Study Participants Procedure Interventions Outcomes Metrics used Results
Banga 2015 106 infants between 32 and 37 weeks PMA
Sucrose group: mean (SD) age (h) at enrolment 3.78 (2.92), mean (SD) birthweight (g) 1555.58 (242.79)
Water group: mean (SD) age (h) at enrolment 3.16 (2.18), mean (SD) birthweight 1575.24 (241.89)		 Repeated potentially painful procedures during the first 7 days after enrolment
Mean (SD) number of procedures:

  1. Sucrose group: 6.15 (1.55)

  2. Water group: 6.15 (1.28)


The authors did not describe which different potentially painful procedures were included (we have written to the corresponding author (drbhanu04@gmail.com) to get a description of these procedures)

  1. Sucrose group (n = 53): 0.5 mL sterile solution 24% sucrose (in 1 mL syringe) for every potentially painful procedure during the first 7 days after enrolment. Analyzed 47 (lost to follow‐up 3, intervention discontinued 1, died 2)

  2. Water group (n = 53): 0.5 mL double‐distilled water ( in 1 mL syringe) for every potentially painful procedure during the first 7 days after enrolment Analyzed = 46 (lost to follow‐up 5, intervention discontinued 0, died 2)

 Primary outcome was score of motor development and vigor (MDV) and alertness and orientation
(AO) domains of NAPI scale performed at 40 weeks PMA
In addition, the highest HR and lowest SpO2 obtained during the procedure were recorded till 30 s after the prick, for newborns in both the groups (not reported)		 Means, SDs, 95% CIs A total of 93 newborns were analyzed. The baseline characteristics of the groups were comparable. No statistically significant difference was observed in the assessment at 40 weeks PMA, among the groups. Use of sucrose analgesia, for repeated painful procedures on newborns, does not lead to any significant difference in the short‐term neurobehavioral outcome
Data used in RevMan‐analyses
Gaspardo 2008 33 preterm infants, median PMA 30 weeks Venipuncture, arterial puncture, heel lance, intravenous cannulation, endotracheal tube introduction, endotracheal tube suctioning, gavage insertion for feeding, removal of electrode leads and tape On day 1, no treatment was given to any neonate in order to collect baseline data. After that, on days 2 to 4 before every minor painful procedure infants received either:

  1. Sucrose group (n = 17): 0.5 mL/kg 25% sucrose

  2. Water group (n = 16): 0.5 mL/kg of sterile water

 Pain was assessed over 4 days during morning blood collection (heel lance)
Incidence of cry (% neonates crying), HR (% neonates with HR ≥ 160 beats per min),
NFCS (% neonates with score ≥ 3), Activated Behavioural State (% neonates with score ≥ 4). The assessment was divided into five phases: Baseline Antisepsis, Puncture, Dressing, and Recovery. The neonates’
 facial activity (NFCS), behavioural state, and HR were evaluated		 No means or standard deviations reported
NFCS results reported in graph form only		 The data analysis used cut‐off scores for painful and distressful
 responses. There were significantly fewer sucrose group neonates with facial actions signalling pain than water group neonates in puncture phase and in antisepsis phase. There were significantly fewer sucrose group neonates crying during antisepsis phase, puncture phase, and dressing phase. There was no statistical difference between groups for physiological response. The efficacy of sucrose was maintained for pain relief in preterm neonates with no side effects
Data could not be used in RevMan‐analyses
No side effects of using sucrose were detected
Johnston 2002 103 infants:

  1. Sucrose group: mean PMA 28.18 (1.72)

  2. Water group: mean PMA 28.05 (2.06)

 Every time the infant was to undergo an invasive (e.g. heel lance, intravenous cannulation, arterial puncture, injection) or non‐invasive but presumably uncomfortable procedure (e.g. endotracheal tube suctioning, tape or
 lead removal, gavage insertion for feeding) the infant received sucrose or water

  1. Sucrose group (n = 51): 0.1 mL 24% sucrose in sterile refrigerated syringe

  2. Water group (n = 52): 0.1 mL water in sterile refrigerated syringe


The solution was in a syringe and administered into the infant’s mouth at the beginning of the procedure, 2 min into the procedure, and another 2 min into the procedure. If the procedure was > 15 min, up to another 3 0.1 mL doses were to be given 2 min apart		 Neurobehavioural development assessed by the sub scales of alertness and orientation and motor development and vigour of the NAPI, SNAP and NBRS
SNAP was measured for each 24‐hour period during the study week and NBRS was measured at 2 weeks’ PNA and at discharge		 Beta, CI (multiple regression) On the basis of analysis of covariance with PMA at birth and the number of invasive procedures as covariates, there were no group differences (between sucrose and water) for any of the secondary outcomes of Neuro‐Biological Risk Scores (NBRS) at two weeks; postnatal age (P = 0.426) or at discharge (P = 0.965). In the sucrose group only, higher number of doses of sucrose predicted lower scores on motor development and vigor, and alertness and orientation at 36 weeks’, lower motor development and vigor at 40 weeks’, and higher NBRS at 2 weeks’ postnatal age. Higher number of invasive procedures was predictive of higher NBRS both times in the water group.
No significant differences found between the sucrose and water groups for Neurobehavioral Assessment of the Preterm Infant (NAPI).
Data could not be used in RevMan‐analyses
Taddio 2008 240 newborn infants born to non‐diabetic and diabetic mothers, PMA ≥ 36 weeks 3 heel lances, venipuncture and intramuscular vitamin K injection
Multiple painful stimuli

  1. 2 mL 24% sucrose given to infants of non‐diabetic mothers (n = 60)

  2. 2 mL 24% sucrose given to infants of diabetic mothers (n = 60)

  3. 2 mL sterile water given to infants of non‐diabetic mothers (n = 60)

  4. 2 mL sterile water given to infants of diabetic mothers (n = 60)

 PIPP scores overall, during IM injection, during venipuncture and all 3 heel lances
Safety		 Mean, SD, 95% CI Overall PIPP scores were significantly lower among newborns given sucrose (mean 6.8, SD 2.9) compared to water (mean 8.1, SD 2.5) (MD ‐1.3, 95% CI ‐2.0 to ‐0.6; P < 0.001)
PIPP scores during IM injection did not differ between the sucrose and water group for non‐diabetic (P = 0.10) or diabetic mothers (P = 0.15)
PIPP scores during venipuncture were significantly lower among infants of non‐diabetic mothers who received sucrose compared to water (mean score 5.7, 95% CI 4.7 to 6.7 vs. mean score 8.9, 95% CI 7.9 to 9.9; P < 0.001). Similar results were found among infants of diabetic mothers (sucrose: mean score 6.8, 95% CI 5.7 to 7.9 vs. water: mean score 9.2, 95% CI 8.4 to 10.1; P < 0.001)
During first 3 heel lances, newborns from diabetic mothers receiving sucrose or water did not have significantly different PIPP scores
Results for different painful stimuli reported separately
Data could be used in RevMan‐analyses

Abbreviations

CI = confidence interval
 PMA = gestational age
 HR = heart rate
 IM = intramuscular
 MD = mean difference
 NAPI = Neurobehavioral Assessment of the Preterm Infant
 NBRS = Neuro‐Biological Risk Score
 NFCS = Neonatal Facial Coding System
 PCA = postconceptional age
 PIPP = Premature Infant Pain Profile
 PMA = postmenstrual age
 PNA = postnatal age
 SD = standard deviation
 SNAP = Score for Neonatal Acute Physiology
 SpO2 = oxygen saturation