Nonpharmacological Pain Management in Neonates

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.

Conditions

• Pain Management
• Neonates Pain Management

Interventions

BEHAVIORAL

no intervention

Group 4 will receive no intervention

DRUG

nonnutritive suckling

Group 1 will receive nonnutritive suckling

DRUG

oral glucose 25%

Group 2 will receive oral glucose 25%

BEHAVIORAL

facilitated tuckling

Group 3 will undergo facilitated tuckling

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Safaa Mustafaa Abo Zaid, pediatric resident · Assiut University

• Zeinab Mohie Eldeen, professor · Assiut University

• Amira Mohamed shalaby, Assistant Professor · Assiut University

• Randa AbdAlbadea Abdelaleem, Lecturer of Pediatrics · Assiut University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

32 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2024-12-01

Completion

2025-02-01