The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-05-31

Brief Summary

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Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Palmar aspect of participants forearms will be randomized to have either a cold compress pack or a room temperature compress pack placed on it. The cold compress pack serves as the trial intervention and the room temperature compress pack serves as the placebo. Each forearm will then be injected with both a 3:1 (experimental ratio) and a 9:1 (standard ratio) mixture of lidocaine with epinephrine:sodium bicarbonate in a randomized order.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participants will be blind to the solution ratio of each injection, injector will not be blind to solution to ensure safety.

Intervention Type DRUG

Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate

Interventions

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Cold Compress Pack

Palmar aspect of forearm will have a cold compress pack placed on it.

Intervention Type OTHER

Room Temperature Compress Pack

Palmar aspect of forearm will have a room temperature compress pack placed on it.

Intervention Type OTHER

Lidocaine Epinephrine

Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate

Intervention Type DRUG

Lidocaine Epinephrine

Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate

Intervention Type DRUG

Other Intervention Names

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Lidocaine Epinephrine buffered with Sodium Bicarbonate Lidocaine Epinephrine buffered with Sodium Bicarbonate

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures
* Any gender, aged 21 - 65
* In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
* Healthy intact skin on the palmar aspect of both left and right forearms
* Fluent in English

Exclusion Criteria

* Current use of any medication
* Pregnancy
* Known allergic reactions to components of the local anesthetic such as sulfites
* History of vasovagal response to venipuncture or vaccination
* History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
* Decreased sensation to the palmar aspect of either forearm

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes