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OpenTrials
Completed

NCT Number: NCT04473820

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IKCH

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapocoolant spray

Drug

The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.

lidocaine-prilocaine cream

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2020
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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