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

NCT05462964 | Completed

• 1 other identifier: UludagUniversity-AKKAYAGUL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Neonatal; Orogastric tube; Pacifiers; %25 Dextrose; NIPS

Outcome Measures

Primary Outcomes (4)

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.

  Pre-procedure

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.

  During the procedure

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.

  1st minute after OGT placement.

• Neonatal Infant Pain Scale (NIPS)

  The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.

  3rd minute after OGT placement.

Secondary Outcomes (7)

• Highest Heart Rate

  Within 15 seconds before OGT insertion

• Highest Heart Rate

  During the procedure

• Highest Heart Rate

  3 minutes after insertion

• Lowest Oxygen Saturation

  Within 15 seconds before OGT insertion

• Lowest Oxygen Saturation

  During the procedure

Study Arms (3)

Control Group

NO INTERVENTION

Newborns in this group were started to camera recording 2 minutes before the procedure and routine OGT placement was performed. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the recording was stopped.After OGT insertion, a light touch was provided if necessary to ensure routine comfort of the baby for ethical reasons.

İntervention Group 1

EXPERIMENTAL

Only a pacifier was given to the newborn.

Behavioral: Pacifiers Group (İntervention Group 1)

İntervention Group 2

EXPERIMENTAL

The newborn was given a pacifier sweetened with 25% dextrose.

Behavioral: Pacifier group sweetened with 25% dextrose (İntervention Group 2)

Interventions

Pacifiers Group (İntervention Group 1) BEHAVIORAL

Camera recording was started 2 minutes before OGT placement and only a pacifier was given to the newborn. After the pacifier in the OGT intervention group was placed in the mouth of the given baby in the form of leaking from the mouth, it was inserted by advancing the baby's swallowing reflex from the esophagus to the stomach. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the recording was stopped.

İntervention Group 1

Pacifier group sweetened with 25% dextrose (İntervention Group 2) BEHAVIORAL

Camera recording was started 2 minutes before OGT insertion and the newborn was given a pacifier sweetened with 25% dextrose. After the dextrose-sweetened pacifier in the OGT intervention group was placed in the mouth of the baby in the form of a leak from the mouth, it was inserted by advancing the baby's esophagus and then to the stomach with the swallowing reflex of the baby. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the registration was stopped.

İntervention Group 2

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies are term newborns with 38-42 weeks of gestation,
• Having a newborn for whom only OGT insertion will be attempted,
• Having a newborn who did not receive any painful stimuli until 30 minutes before the intervention,

You may not qualify if:

• Newborns with any congenital anomalies of the face or oral cavity,
• Newborns with 3rd and 4th degree intraventricular hemorrhage,

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University

Bursa, Nilufer, 16059, Turkey (Türkiye)

Location

Related Publications (1)

• Akkaya-Gul A, Ozyazicioglu N. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial. J Perinatol. 2024 May;44(5):717-723. doi: 10.1038/s41372-024-01948-w. Epub 2024 Mar 29.

  PMID: 38553602 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 18, 2022
• Study Start: December 25, 2018
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

TU (1)