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

N

Nicholas Bastidas

Status

Withdrawn

Conditions

Pain

Treatments

Drug: Lidocaine Epinephrine
Other: Cold Compress Pack
Other: Room Temperature Compress Pack

Study type

Interventional

Funder types

Other

Identifiers

NCT04991597
LESB 001

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

0 participants in 2 patient groups

Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature
Experimental group
Description:
Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
Treatment:
Drug: Lidocaine Epinephrine
Other: Cold Compress Pack
Drug: Lidocaine Epinephrine
Other: Room Temperature Compress Pack
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature
Experimental group
Description:
Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
Treatment:
Drug: Lidocaine Epinephrine
Other: Cold Compress Pack
Drug: Lidocaine Epinephrine
Other: Room Temperature Compress Pack

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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