Nonpharmacological Pain Management in Neonates

November 26, 2023 updated by: Safaa Mustafaa Abu Zaid, Assiut University

Nonpharmacological Pain Management in Neonate (A Randomized Controlled Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Safaa Mustafaa Abu Zaid, Resident of Pediatrics
  • Phone Number: 01116318762 01098067714
  • Email: safaamustafaa5@gmail.com

Study Contact Backup

  • Name: Randa AbdAlbadea Abdelaleem, Lecturer of Pediatrics
  • Phone Number: 01003895236
  • Email: randakandeel@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 4 (placebo)
this group will be A control group receive no intervention.
Behavioral: no intervention
Group 4 will receive no intervention
Experimental: group 1 (interventional group)
Intervention groups which will receive nonnutritive suckling.
Drug: nonnutritive suckling
Group 1 will receive nonnutritive suckling
Experimental: group 2 (interventional group )
Group 2 will receive oral glucose 25%
Drug: oral glucose 25%
Group 2 will receive oral glucose 25%
Experimental: Group 3 (interventional group)
Group 3 will undergo facilitated tuckling
Behavioral: facilitated tuckling
Group 3 will undergo facilitated tuckling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRIES SCORE
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Safaa Mustafaa Abo Zaid, pediatric resident, Assiut University
  • Study Director: Zeinab Mohie Eldeen, professor, Assiut University
  • Study Director: Amira Mohamed shalaby, Assistant Professor, Assiut University
  • Study Director: Randa AbdAlbadea Abdelaleem, Lecturer of Pediatrics, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Estimated)

December 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • pain management in neonate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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