Investigation of the Efficacy of Pain Relief Using Sucrose and Pacifier in Fundus Examination

UMIN ID: UMIN000054536

Registered date:14/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Retinopathy of prematurity
• Date of first enrollment: 2024/07/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Two minutes prior to fundus examination, 0.15 cc of "P-Less care sucrose 24% solution," a standardized food for infants, is administered.
Two minutes prior to fundus examination, the patient is given a non-nutritive sucking with a pacifier.
Control without intervention.

Outcome(s)

• Primary Outcome: The Japanese version of PIPP (Premature Infant Pain Profile) is used to evaluate the pain score from the patient's behavioral status and vital signs from 15 seconds before fundus examination to 30 seconds after right eye examination.
• Secondary Outcome: A sound level meter is used to evaluate the patient's crying during the examination. The sound level meter measures a 1-second average and determines that crying is present when it exceeds 80 dB.

Key inclusion & exclusion criteria

• Age minimum: 30weeks-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Who require airway management or are using insulin preparations.

Related Information

• Primary Sponsor: Tokushima University
• Source(s) of Monetary Support: None