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临床试验/NCT06155825
NCT06155825尚未招募不适用

Nonpharmacological Pain Management in Neonate (A Randomized Controlled Study)

Assiut University0 个研究点目标入组 164 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
164
主要终点
CRIES SCORE

研究概览

简要总结

This is A randomized controlled study which aim to:

The primary aim in this study is assessment of non-pharmacological pain management in neonate and determine the most effective.

The secondary aim of this study is to introduce idea of neonatal pain management. and record its effect on hospital stay and Duration to reach full enteral feeding. This prospective study will be conducted at NICU unit of Assiut University pediatrician hospital, Duration of study 1 year from 1/12/2023 to 1/12/2024.

one hundred sixty-four children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion, venipuncture, arterial puncture, heel prick, Group 1 will receive nonnutritive suckling. Group 2 will receive oral glucose 25% Group 3 will undergo facilitated tuckling Group 4 will be a control group (receive no nonpharmacological intervention). The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions.

Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.

详细描述

Pain is defined as unpleasant sensory and emotional experience associated with tissue damage. Newborns are especially vulnerable to pain and its deleterious effects, as they have larger receptive fields for nociceptive impulses and possibly a higher density of nerve endings and concentration of substance P receptors 1) . The density of proprioceptive nerve ending is equal to the adult, also they have a lower threshold for excitation and sensitization.

In neonates the harmful effects of pain include irritability, fear, sense of mistrust towards caregiver, disturbed sleep and wakefulness cycle, delayed wound healing, altered immunological functions, biochemical alterations in energy metabolism2), negative effects on the developing brain and behavior. Neonates requiring intensive care admission exposed to various types of painful stimuli such as venipuncture, arterial puncture, suction, catheterization or invasive procedures as, lumbar puncture, CVC and bronchoscopy.

The responses to pain in a newborn are nonverbal and include physiological and autonomic manifestations as changes in heart rate, respiratory rate, blood pressure and oxygen saturation3), also behavioral changes as crying, change in facial expressions and body movement. These parameters are used for pain assessment in various scales4). For example, total facial activity and cluster of specific facial findings (brow bulge, eye squeeze, nasolabial furrow, open mouth) were associated with acute and postoperative pain5*6).

Example of most commonly used scales in assessment of pain7), the Premature Infant Pain Profile (PIPP)8), Neonatal Pain Agitation and Sedation Scale (N-PASS)9), Neonatal Infant Pain Scale (NIPS) and the CRIES scale (Crying, Requires Oxygen Saturation, Increased Vital Signs, Expression, Sleeplessness).12)

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
None

入排标准

年龄范围
32 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy term newborn 32 week or more.
  • Newborn during routine painful maneuvers as venipuncture and arterial puncture

排除标准

  • Preterm < 32 week 2) Newborn with neurological impairment 3) Sedated newborn 4) Newborn with metabolic diseases 5) Newborn with congenital anomalies 6) Newborn undergoing operative intervention

研究组 & 干预措施

Group 4 (placebo)

Placebo Comparator

this group will be A control group receive no intervention.

干预措施: no intervention (Behavioral)

group 1 (interventional group)

Experimental

Intervention groups which will receive nonnutritive suckling.

干预措施: nonnutritive suckling (Drug)

group 2 (interventional group )

Experimental

Group 2 will receive oral glucose 25%

干预措施: oral glucose 25% (Drug)

Group 3 (interventional group)

Experimental

Group 3 will undergo facilitated tuckling

干预措施: facilitated tuckling (Behavioral)

结局指标

主要结局

CRIES SCORE

时间窗: one year

164 children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion. Group 1,2,3 will be receiving nonpharmacological interventions Group 4 will be a control group. The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, Requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions. Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safaa Mustafaa Abu Zaid

pediatric resident

Assiut University

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