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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04473820
Enrollment
77
Registered
2020-07-16
Start date
2024-02-16
Completion date
2024-05-31
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

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.

Interventions

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

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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cannulation pain: numerical rating score (NRS)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

MeasureTime frameDescription
Application pain: numerical rating score (NRS)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.
Catheterization attemptsimmediately 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026