Comparison of Lidocaine-Prilocaine Combination and Vapocoolant for IV Cannulation Pain in the ED

May 31, 2024 updated by: Hadi Mirfazaelian, Tehran University of Medical Sciences

Comparison of The Efficacy of Lidocaine-Prilocaine Combination and Vapocoolant Spray to Reduce Pain of IV Cannulation in The Emergency Department: A Randomized Clinical Trial

Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lidocain-Prilocaine combination cream is two amide-type local anesthetics used for topical skin anesthesia. Vapocoolant spray is also another method for providing appropriate analgesia through crayoanesthetic mechanisms. Although there are some contraindications and adverse effects, these are widely used in the Emergency Department (ED) for IV cannulation pain.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low acute patients who are waiting for the admission to the ED and require IV cannulation

Exclusion Criteria:

  • Altered mental status
  • Uncooperative patients
  • Unable to communicate
  • Known history of hypersensitivity reaction to cold or amid analgesics
  • Analgesic usage in previous 6 hours
  • No consent
  • Emergent condition
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vapocoolant spray
Patients in this arm will receive vapocoolant spray before IV cannulation.
Drug: Vapocoolant spray
The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.
Active Comparator: Lidocaine-Prilocaine cream
Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.
Drug: Lidocaine-Prilocaine cream
A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation pain: numerical rating score (NRS)
Time Frame: immediately after the procedure.
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
immediately after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application pain: numerical rating score (NRS)
Time Frame: immediately after the procedure.
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
immediately after the procedure.
Catheterization attempts
Time Frame: immediately after the procedure.
Number of times the direction of IV catheter is changed before the successful cannulation. Exit from the skin is also considered an attempt.
immediately after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9111215292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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