Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-24

Study Completion Date

2019-05-01

Brief Summary

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Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method.

In this study, the investigators evaluated the effectivity of three non-invasive analgesic techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead injections, in a series of 100 healthy volunteers.

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Detailed Description

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This study is a randomized, controlled, simple-blind clinical trial, and it has been approved by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included 100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La Fe, Valencia.

The procedures of the study consisted in the sequential performance of four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization. Injections always started from the right side of the forehead to the left. The non-invasive analgesic methods utilized were:

* Control zone: None
* Vibration: Application of the vibrating device on the skin below the injection site, before and during injection.
* Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds prior to performing the injection.
* Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes, before injection.

Conditions

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Injection Pain Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All subjects received four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead, 2cm above the eyebrows, with a 29G needle, after applying each one of the 4 non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes were studied by an investigator that did not participate in the practical part of the trial.

Study Groups

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Control

A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, without administering any type of non-invasive analgesic

Group Type PLACEBO_COMPARATOR