Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
164 participants
INTERVENTIONAL
2023-12-01
2025-02-01
Brief Summary
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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.
Detailed Description
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 4 (placebo)
this group will be A control group receive no intervention.
no intervention
Group 4 will receive no intervention
group 1 (interventional group)
Intervention groups which will receive nonnutritive suckling.
nonnutritive suckling
Group 1 will receive nonnutritive suckling
group 2 (interventional group )
Group 2 will receive oral glucose 25%
oral glucose 25%
Group 2 will receive oral glucose 25%
Group 3 (interventional group)
Group 3 will undergo facilitated tuckling
facilitated tuckling
Group 3 will undergo facilitated tuckling
Interventions
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no intervention
Group 4 will receive no intervention
nonnutritive suckling
Group 1 will receive nonnutritive suckling
oral glucose 25%
Group 2 will receive oral glucose 25%
facilitated tuckling
Group 3 will undergo facilitated tuckling
Eligibility Criteria
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Inclusion Criteria
2. Newborn during routine painful maneuvers as venipuncture and arterial puncture
Exclusion Criteria
32 Weeks
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Safaa Mustafaa Abu Zaid
pediatric resident
Principal Investigators
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Safaa Mustafaa Abo Zaid, pediatric resident
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Zeinab Mohie Eldeen, professor
Role: STUDY_DIRECTOR
Assiut University
Amira Mohamed shalaby, Assistant Professor
Role: STUDY_DIRECTOR
Assiut University
Randa AbdAlbadea Abdelaleem, Lecturer of Pediatrics
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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Safaa Mustafaa Abu Zaid, Resident of Pediatrics
Role: CONTACT
Phone: 01098067714
Email: [email protected]
Randa AbdAlbadea Abdelaleem, Lecturer of Pediatrics
Role: CONTACT
Phone: 01003895236
Email: [email protected]
References
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Krechel SW, Bildner J. CRIES: a new neonatal postoperative pain measurement score. Initial testing of validity and reliability. Paediatr Anaesth. 1995;5(1):53-61. doi: 10.1111/j.1460-9592.1995.tb00242.x.
Castagno E, Fabiano G, Carmellino V, Cerchio R, De Vito B, Lauria B, Mercurio G, Coscia A, Ponte G, Bondone C. Neonatal pain assessment scales: review of the literature. Prof Inferm. 2022 Apr 1;75(1):17-28. doi: 10.7429/pi.2022.751017. English, Italian.
Bucsea O, Pillai Riddell R. Non-pharmacological pain management in the neonatal intensive care unit: Managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019 Aug;24(4):101017. doi: 10.1016/j.siny.2019.05.009. Epub 2019 Jun 5.
Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, Nimbalkar S. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2018 Apr 15;55(4):292-296. Epub 2018 Feb 9.
Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
Other Identifiers
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pain management in neonate
Identifier Type: -
Identifier Source: org_study_id