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
1 other identifier
interventional
77
1 country
1
Brief Summary
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pain
Started Feb 2024
Shorter than P25 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedStudy Start
First participant enrolled
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJune 4, 2024
May 1, 2024
2 months
July 10, 2020
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Application pain: numerical rating score (NRS)
immediately after the procedure.
Catheterization attempts
immediately after the procedure.
Study Arms (2)
Vapocoolant spray
ACTIVE COMPARATORPatients in this arm will receive vapocoolant spray before IV cannulation.
Lidocaine-Prilocaine cream
ACTIVE COMPARATORPatients in this arm will receive Lidocaine-Prilocaine cream before IV cannulation.
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.
Eligibility Criteria
You may qualify if:
- Low acute patients who are waiting for the admission to the ED and require IV cannulation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IKCH
Tehran, Iran
Related Publications (1)
Akhgar A, Mazidabadi Farahani A, Akbari H, Sedaghat M, Jalili M, Mirfazaelian H. Comparison of the effects of vapocoolant spray and topical anaesthetic cream (lidocaine-prilocaine) on pain of intravenous cannulation: a randomised controlled trial. Emerg Med J. 2025 May 22;42(6):373-377. doi: 10.1136/emermed-2024-214479.
PMID: 40118519DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 16, 2020
Study Start
February 16, 2024
Primary Completion
April 29, 2024
Study Completion
May 31, 2024
Last Updated
June 4, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share