A Randomized Double-blind Trial Comparing the Effect on Pain of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Venipuncture

INTRODUCTION AND JUSTIFICATION

Acute pain is one of the most common adverse stimuli experienced by children, occurring as a result of injury, illness, and necessary medical procedures[1]. The American Academy of Pediatrics (AAP) and the American Pain Society (APS) have jointly issued a statement promoting the responsibility of paediatricians as leaders and advocates to ensure the humane and competent treatment of pain and suffering in all infants, children, and adolescents[1]. In Emergency Departments (ED), children undergo many painful procedures, such as bladder catheterization, capillary blood tests, venipuncture and lumbar puncture. All these procedures are associated with increased anxiety, avoidance, somatic symptoms, and increased parental distress[1]. Numerous myths, insufficient knowledge among caregivers, and inadequate application of knowledge contribute to a lack of effective pain management among infants[1].

Long-term effects of unmanaged pain in human infants have been shown to include permanent impairment of elements of cognitive development, such as learning, memory, and behaviour[2], and increased somatisation in childhood[3]. The plasticity of the developing brain and the changes that occur in response to painful stimuli[4] also contribute to altered perceptions of pain later in life[5-6]. Early painful experiences affect children's future responses to analgesia. Weisman et al[7] found that inadequate analgesia in young children during procedures diminished the effects of adequate analgesia during subsequent procedures. Many studies have suggested that the prompt and accurate recognition and treatment of pain in young infants is important for their immediate comfort and for their best possible lifelong development[8]. Despite the recent interest in paediatric pain assessment, prevention and treatment, many children do not receive adequate management to alleviate pain[1, 8-9]. The ideal pre-procedural analgesic for minor invasive procedures would be a cost-effective, inexpensive, short-acting agent with few associated risks[10].

The use of sucrose has been well studied for certain procedures in the patients of the neonatal intensive care unit and in the newborn nursery settings, particularly for venous blood draws, capillary blood tests and circumcision[11-13]. In these studies[11-13], infants receiving oral sucrose solutions before procedures cried less and had overall decreased behavioural pain responses when compared with those receiving placebo. Furthermore, sucrose has been shown to be a safe intervention with no serious life-threatening adverse events and only few reported side effects consisting of minimal coughing with administration[14]. Sucrose is inexpensive, short acting, non-sedating, easily administered and non-invasive. Administration of sucrose does not require additional training and does not expose the infant to risks greater than those associated with breast or bottle feeding.

Summaries of randomized controlled trials among hospitalized neonates of 32 to 40 weeks of gestation suggest that a single dose of 0,5 to 2 mL of 12% to 50% sucrose delivered by non-nutritive sucking via a pacifier for 2 minutes before a painful event is safe[15] and effective in decreasing physiologic (heart rate, respiratory rate and oxygen saturation)[16-17]. It is also effective in minimizing behavioural pain indicators (crying, facial expression and motor activity)[16, 18] and in reducing overall composite pain scale scores[16]. A Cochrane systematic review concluded that sucrose is safe and effective in reducing procedural pain from single short procedural events in neonates, but an optimal dose could not be identified due to inconsistency in effective sucrose dosage among studies[19]. A review of published studies reported that sucrose or glucose in healthy term or preterm infants during single episodes of heel lancing, venipuncture or intramuscular injection is effective[20]. However, uncertainties remain beyond the neonatal period, given the limited number of published studies [20].