The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration

NCT05465694 | Completed

• 1 other identifier: GEAH.Denizyaprak.137470
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose. It has been demonstrated clearly that sucrose solutions given before a minor painful procedure can reduce pain among newborns. But, there are no entirely accepted conclusions about the time scheduling of sucrose administration prior to heel lance. In a few studies, various time intervals between sucrose intake and heel lance procedure have been proposed. The aim of this study was to obtain a deeper knowledge of the underlying mechanism by investigating whether a different initiation of heel lance in terms of timing would reduce the effect of orally administered sucrose at heel lance among preterm newborns. Methods. A randomized, double-blind trial with a validated, neonatal, pain-scoring scale in Gulhane Medical School Hospital in Ankara, Turkey between March 2019 and January 2021. The trial included 69 preterm newborns undergoing heel lance, who were assigned randomly to 1 of 2 groups, ie, group I, with the 2-minute-time interval of per oral 24% sucrose given prior to heel lance or group II, without a time interval of per oral sucrose given prior to heel lance. Pain-related behavior during blood sampling was measured with the Premature Infants Pain Profile-Revised (PIPP-R). Crying incidence, duration, and heart rate were also recorded. The aim of this study was to help to clarify the mechanism underlying the pain-reducing effect of orally administered sucrose by attempting to determine whether elimination of the time interval prior to heel lance would reduce the effect of oral sucrose among preterm newborns. Investigators hypothesized that there would be a significant difference in pain intensity without a waiting period after sucrose ingestion, measured at 30 and 60 s following heel lance using PIPP-R, and adverse events would be higher.

Conditions

Neonatal Disease; Pain, Acute

Keywords

preterm; pain; sucrose; dopamine

Outcome Measures

Primary Outcomes (2)

• Premature Infant Pain Profile-Revised (PIPP-R)

  The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of \<7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.

  30 seconds

• Premature Infant Pain Profile-Revised (PIPP-R)

  The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of \<7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.

  60 seconds

Secondary Outcomes (4)

• Crying incidence

  120 seconds

• Crying duration

  120 seconds

• Heart rate

  30 seconds

• Heart rate

  60 seconds

Study Arms (2)

2-minute-time interval of per oral 24% sucrose

ACTIVE COMPARATOR

For infants in the 2-minute-time interval of per oral 24% sucrose was given prior to the heel lance intervention.

Procedure: 2-minute-time interval of per oral 24% sucrose

no time interval of per oral 24% sucrose

ACTIVE COMPARATOR

In no time interval of sucrose was given immediately prior to heel lance intervention.

Procedure: no time interval of per oral 24% sucrose

Interventions

2-minute-time interval of per oral 24% sucrose PROCEDURE

Experiment began with a five-minute observation period of all outcome measures while infant was resting in an incubator. Later, attendant nurse gave 1 ml of 24% sucrose solution on neonate's tongue. In the 2-two minute-time interval prior to heel lance intervention, following two minutes of waiting period, heel lance procedure was applied to infant's foot. In no time interval of sucrose given immediately prior to heel lance intervention, attendant nurse performed heel lance procedure immediately after giving 1 ml of 24% sucrose solution sucrose on tongue. Infant's facial actions and heart rate, and oxygen saturation were recorded by using two video cameras. Recording was carried out by a nurse during whole procedure. After collecting data, researcher watched videos separately and scored them by using PIPP-R. Measurement of study outcome relied on data collection strategies: Neonatal close-up video recording of infant facial actions, pulse oximeter, observation for adverse events.

2-minute-time interval of per oral 24% sucrose

no time interval of per oral 24% sucrose PROCEDURE

no time interval of per oral 24% sucrose

no time interval of per oral 24% sucrose

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants who are premature born ( ≥ 27 0/7 weeks of gestation)
• Infants who are at the postconceptional age from 34 0/7- 37 6/7 weeks of gestation
• Normal enterally fed with human milk or formula
• Infants whose mothers consented to study participation

You may not qualify if:

• Infants who were born depressed or with birth trauma
• Infants who have previous surgery
• Infants who have an intraventricular hemorrhage
• Infants who show signs of respiratory distress
• Infants who have an infection
• Infants with significant genetic disorders
• Infants who were on sedatives, muscle relaxants, and antiepileptic
• Infants who were born to opioid-using mothers
• Infants whose parents were unable to provide written informed consent

Sponsors & Collaborators

• Gulhane School of Medicine: lead
• Ankara University: collaborator

Study Sites (1)

University of Health Sciences, Gulhane Medicine Faculty, Department of Pediatrics, Division of Neonatology

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases; Acute Pain; Premature Birth; Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Deniz Yaprak, MD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: March 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: March 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)