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Cold Spray for Insulin-Injection Pain in the Emergency Department

NCT07728162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Abant Izzet Baysal University

    lead OTHER

Principal Investigators

  • Faruk Danis · Abant Izzet Baysal University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728162 on ClinicalTrials.gov