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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473820
• Other study ID #: 9111215292
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 31, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	IKCH	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannulation pain: numerical rating score (NRS)	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	Application pain: numerical rating score (NRS)	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	Catheterization attempts	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.