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临床试验/NCT01544946
NCT01544946已完成4 期

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 Nasopharyngeal Aspiration

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Difference in pains scores related to nasopharyngeal aspiration

研究概览

简要总结

Background: Early recognition and treatment of pain among children is important for their cognitive development and their future response to pain throughout their life. Oral sweet solutions have been accepted as effective pain reducing agents for procedures in the neonatal population. To date, there have been a limited number of published clinical trials in an emergency setting studying this type of intervention among infants undergoing venous puncture and bladder catheterization. These studies have reported conflicting results. No previous studies have evaluated the utilization of sucrose to manage pain during nasopharyngeal aspiration.

Objective: To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children one to three months of age during nasopharyngeal aspiration in the Emergency Department.

详细描述

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 procedures1. 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.

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 behavior, and increased somatisation in childhood. The plasticity of the developing brain and the changes that occur in response to painful stimuli also contribute to altered perceptions of pain later in life. Early painful experiences affect children's future responses to analgesia. Weisman et al 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. Despite the recent interest in paediatric pain assessment, prevention and treatment, many children do not receive adequate management to alleviate pain. The ideal pre-procedural analgesic agent for minor invasive procedures would be a cost-effective, inexpensive, short-acting agent with few associated risks.

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. In these studies, infants receiving oral sucrose solutions before procedures cried less and had overall decreased behavioral 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. 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.

Nasopharyngeal aspiration (NPA) is a common procedure in the Emergency Department (ED), especially during wintertime. It is also a recognized way to support small children with bronchiolitis or upper respiratory viral illness. There is currently a paucity of literature about the perception of pain or discomfort during nasopharyngeal aspiration. Macfarlane and al. compared nasal swab versus nasopharyngeal aspirate for RSV testing in children of 1 month to 20 months. Infant distress was measured using a facial, cry, and movement scoring scale (FLACC). A median score of six was obtaining in the group of nasopharyngeal aspirate in comparison of median score of cinq for nasal swab (p<0,0001).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants from one to three months (one month or more but less than three months old) of actual age (not corrected) requiring a nasopharyngeal aspiration as a part of their planned ED management during weekdays from 8h to 16h.

排除标准

  • Preterm infants (i.e. born <37 weeks)
  • Chronic cardio-pulmonary condition
  • Assisted ventilation (such as tracheostomy or oxygen dependance)
  • Technology dependant (such as enteral feeding tubes)
  • Oropharyngeal malformation or dysfunction (such as cleft palate or micrognatia)
  • Previous participation in this study
  • Painful procedures in the preceding 60 minutes (bladder catheterization, vesical puncture, lumbar puncture, capillary blood tests)
  • Parental language barrier (French and/or English)

研究组 & 干预措施

sucrose po

Experimental

干预措施: 88% sucrose po (Drug)

placebo po

Placebo Comparator

干预措施: placebo po (Drug)

结局指标

主要结局

Difference in pains scores related to nasopharyngeal aspiration

时间窗: one minute

次要结局

  • Difference in pain scores related to nasopharyngeal aspiration(3 minutes)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serge Gouin

Associate Professor

St. Justine's Hospital

研究点 (1)

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