NCT05462964

Reducing Pain During Orogastric Tube Insertion in Newborns: Use of Pacifiers and Pacifiers Sweetened With 25% Dextrose

Completed NA Last updated 18 July 2022

What this trial tests

NA trial testing Pacifiers Group (İntervention Group 1) in Pain in 60 participants. Completed in 18 February 2020.

Timeline

25 December 2018

Primary endpoint
18 February 2020

18 February 2020

Quick facts

Lead sponsor	Uludag University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	25 December 2018
Primary completion	18 February 2020
Estimated completion	18 February 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Pacifiers Group (İntervention Group 1)
• Pacifier group sweetened with 25% dextrose (İntervention Group 2)

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Uludag University

Who can join

Adults 38 Weeks to 42 Weeks, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Orogastric tube(OGT) placement, which is used for monitoring, diagnostic and therapeutic purposes, causes pain and stress in premature and term newborns. Non-pharmacological pain intervention with pacifiers and sweetener solutions (sucrose, dextrose, etc.) in newborns is a viable nursing approach to reduce pain. In the limited number of studies in the literature, it was seen that pacifiers and sucrose were used in nasogastric tube(NGT) applications and they were especially focused on premature babies. In our study, due to the fact that it was conducted in term newborns and, unlike the limited number of studies, OGT was placed in the stomach in the form of a pacifier and a 25% dextrose pacifier leaking from the rim. Our study was conducted as a randomized controlled experimental study to examine the effect of using pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement, and also to evaluate the effects on behavioral response and physiological parameters (heart rate, oxygen saturation) in newborns.In addition, it was thought that the fact that the study was carried out by passing a pacifier and a pacifier sweetened with 25% dextrose, would facilitate progress and reduce trauma by stimulating the swallowing reflex in newborns via a pacifier as in adults.The population of the study consisted of term newborns at 38-42 weeks of gestation who were hospitalized in the Neonatal Intensive Care Unit of a hospital in Turkey between April-December 2019. The sample group randomly consisted of 60 newborns (Control group: 20, Intervention group with only pacifiers:20, with dextrose flavored pacifiers:20). 20 babies in the intervention group were given only pacifiers and 20 babies were given a pacifiers flavored with dextrose 2 minutes before the OGT insertion. The procedure was performed by leaking the tube from the edge of the pacifiers. Routine OGT insertion was performed in the control group. The data collection process was recorded with a camera. The Neonatal Infant Pain Scale (NIPS), the highest heart rate and lowest oxygen saturation from physiological pain responses, and crying time from behavioral parameters were evaluated by the researcher by watching the camera recording. Variance analysis, Shapiro Wilk, Kruskal Wallis, Chi-square, Bonferro, and Wilcoxon tests were used in the statistical analysis of the study. The SPSS v22 package program was used for statistical analysis and the significance level was taken at α=0.05.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial.
   Akkaya-Gül A, Özyazıcıoğlu N. · · 2024 · cited 1× · PMID 38553602 · DOI 10.1038/s41372-024-01948-w