drugset / Trial / NCT06155825

Nonpharmacological Pain Management in Neonates

NCT06155825

Unknown 164 enrolled Assiut University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-01
Primary completion
2024-12-01
Completion
2025-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucose Unknown 25 % Oral

Indications

No indication recorded.