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Clinical trial

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

ID
Name
9111215292
Description
Hypothesis: Lidocaine-Prilocaine Combination is as effective as Vapocoolant in treating IV cannulation pain in the emergency department.
Trial arms
Trial start
2024-02-16
Estimated PCD
2024-04-29
Trial end
2024-05-31
Status
Completed
Phase
Early phase I
Treatment
Vapocoolant spray
The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.
Arms:
Vapocoolant spray
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.
Arms:
Lidocaine-Prilocaine cream
Size
77
Primary endpoint
Cannulation pain: numerical rating score (NRS)
immediately after the procedure.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 77, 'type': 'ACTUAL'}}
Updated at
2024-06-04

1 organization

2 products

1 indication

Organization
Tehran University of Medical Sciences
Product
Vapocoolant spray
Indication
Pain
Product
Lidocaine-Prilocaine