Nonpharmacological Pain Management in Neonates

Pain Management Clinical Trial

Official title:

Nonpharmacological Pain Management in Neonate (A Randomized Controlled Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06155825
• Other study ID #: pain management in neonate
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Safaa Mustafaa Abu Zaid, Resident of Pediatrics
• Phone: 01098067714
• Email: safaamustafaa5[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: February 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks and older

Eligibility

Inclusion Criteria:

1. Healthy term newborn 32 week or more.

2. Newborn during routine painful maneuvers as venipuncture and arterial puncture

Exclusion Criteria:

• 1) 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

Related Conditions & MeSH terms

• Pain Management

Intervention

Behavioral:
• no intervention
Group 4 will receive no intervention

Drug:
• nonnutritive suckling
Group 1 will receive nonnutritive suckling
• oral glucose 25%
Group 2 will receive oral glucose 25%

Behavioral:
• facilitated tuckling
Group 3 will undergo facilitated tuckling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. Erratum In: Semin Fetal Neonatal Med. 2021 Apr;26(2):101027. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRIES SCORE	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.	one year