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COMPLETED
NCT07728162
NA

Cold Spray for Insulin-Injection Pain in the Emergency Department

Sponsor: Abant Izzet Baysal University

View on ClinicalTrials.gov

Summary

This randomized, double-blind, placebo-controlled, within-patient crossover trial evaluated whether a vapocoolant (cold) spray applied before subcutaneous insulin injection reduces injection pain compared with a placebo (sterile-water) spray in adults treated in a tertiary-care emergency department. Each participant received a cold spray before one clinically indicated insulin injection and a placebo spray before another, in randomized order, and marked injection pain on a 100-mm visual analog scale 10 seconds after each injection. The within-patient design allowed each participant to serve as their own control.

Official title: Cold Spray for Pain Reduction During Subcutaneous Insulin Injection in the Emergency Department: A Randomized, Placebo-Controlled, Two-Period Crossover Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-02-05

Completion Date

2025-04-01

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

OTHER

Cold (vapocoolant) spray

A vapocoolant (cold) spray applied to the intended abdominal injection site for approximately 10 seconds from approximately 30 cm; the subcutaneous insulin injection was performed approximately 10 seconds later, and the needle was kept in the skin for approximately 10 seconds before withdrawal.

OTHER

Placebo (sterile-water) spray

A sterile-water placebo spray delivered in an identical manner to the active spray (same device handling, distance, and duration) before the subcutaneous insulin injection.

Locations (1)

Bolu Izzet Baysal Training and Research Hospital

Bolu, Turkey (Türkiye)