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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Lidocaine-Prilocaine cream; Drug: Vapocoolant spray

• Registration Number: NCT04473820
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Study Start: 2024-02-16
• Primary Completion: 2024-04-29
• Status Verified: 2024-05
• Study Completion: 2024-05-31
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine-Prilocaine cream	Lidocaine-Prilocaine cream	Patients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.
Vapocoolant spray	Vapocoolant spray	Patients in this arm will receive vapocoolant spray before IV cannulation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 attempts	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.

Trial Locations

Locations (1)

IKCH; 🇮🇷 Tehran, Iran, Islamic Republic of