Be Sweet to Toddlers During Needles: RCT of Sucrose Compared to Placebo
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Cry duration
研究概览
简要总结
The purpose of this study is to determine whether sugar water (24% sucrose) effectively reduces pain in children ages 12 to 36 months undergoing venipuncture, as measured by pain scores and cry duration.
详细描述
Background:
Hospitalized children and children undergoing medical care as outpatients are frequently required to undergo needle-related procedures, such as venipuncture for diagnostic purposes and ongoing monitoring (Ellis, Sharp, Newhook, & Cohen, 2004). This procedure causes considerable pain and distress, especially in young children (Humphrey, Boon, van Linden van den Heuvell, & van de Wiel, 1992). Children rate needles as being the most distressing aspect of hospitalization (Kortesluoma & Nikkonen, 2006; Kortesluoma & Nikkonen, 2004), yet they are the most frequently performed skin-breaking procedure for hospitalized children (Cummings, Reid, Finley, McGrath, & Ritchie, 1996; Ellis, et al., 2004; Rennick, McHarg, Dell'Api, Johnston, & Stevens, 2008; Stevens et al., 2011). It is estimated that one-quarter of adults have developed a fear needles, most likely developed during childhood (Taddio et al., 2010; Wright, Yelland, Heathcote, Ng, & Wright, 2009). Being afraid of needles increases the risk of avoidance of needles for immunizations and medical care (Taddio et al., 2009; Wright, et al., 2009). It is therefore crucial that health care researchers and clinicians determine effective pain management strategies for young children, and consistently use such strategies in clinical care.
Rationale:
There is a paucity of evidence to support efficacy and feasibility of pain management strategies during needle-related painful procedures in young children, and uncertainties exist regarding analgesic effects of sweet solutions beyond infancy.
Objectives:
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 12-36 months, inclusive
- •Children who are patients at CHEO in the 4 East/West or 5 East wards (and overflow unit, when applicable), and the Medical Day Unit
- •Children who require venipuncture for the purpose of medically required venous blood sampling
- •With the exception of the age criteria, children who are eligible to receive sucrose as per the Sucrose CHEO policy for infants
- •Children who have their venipuncture performed by hospital-employed phlebotomists or registered nurses (to ensure standardization of the blood collection procedure)
- •Parents/guardians and children must also be able to understand English or French
排除标准
- •Children who have received a muscle relaxant, opioid analgesic or sedative in the past 24 hours (to ensure there is no interaction effect of these medications which may impact on toddlers' ability to mount a behavioral response to pain)
- •Children who are ineligible to receive sucrose as per the Sucrose CHEO policy
- •Children who are already consuming sweet fluids or foods, or if the mother wishes to breast feed during the procedure will also be excluded
- •Children with known or suspected fructose intolerance
研究组 & 干预措施
24% sucrose + standard care
In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml 24% sucrose will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure
干预措施: 24% sucrose (Drug)
24% sucrose + standard care
In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml 24% sucrose will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure
干预措施: Standard care (Other)
Sterile water + standard care
In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml sterile water will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure
干预措施: Sterile water (Drug)
Sterile water + standard care
In addition to standard care (topical anesthetic (Ametop or EMLA) + upright holding + distraction + pacifier, if used), a maximum of 2 ml sterile water will be administered orally in 0.25 ml aliquots 2 minutes prior to the needle insertion, at the time of needle insertion, and repeated at 2 minute intervals until the completion of the procedure
干预措施: Standard care (Other)
结局指标
主要结局
Cry duration
时间窗: Cry time will be measured from the time of needle insertion up to 30 seconds after the end of the venipuncture procedure
Cry is a valid measure of distress in young children and is an objective and easily measurable parameter.
次要结局
- FLACC (Face, Legs, Arms, Crying, Consolability)(FLACC scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure)
- MBPS (Modified Behavioural Pain Scale)(MBPS scores will be completed before and during the procedure and up to one minute after the end of the venipuncture procedure)
- Child's compliance with intervention(up to one minute)
研究者
Denise Harrison
Chair in Nursing Care of Children, Youth and Families
Children's Hospital of Eastern Ontario