Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443255
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-05-29
Brief Title:
Cocaine Lidocainexylometazoline and Saline for Nasal Analgesia
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Comparison of Cocaine Lidocainexylometazoline and Saline for Intranasal Analgesia - a Blinded Triple Crossover Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When performed by trained personnel nasotracheal intubation is a safe and effective technique for attaining a secure airway in preparation for surgery of the head and neck The procedure can be deemed necessary due to the nature of the surgical procedure or considerations in regard to the patients comorbidities For a certain group of patients with expected difficult airways the procedure is done whilst they are awake and aided by fiberoptics
For these awake patients extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion providing more space within the nasal cavity For these purposes several drugs in varying combinations and dosages are used but no single drug choice is universally recommended
Cocaine is one of these appropriate drugs It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties Concerns have though been raised regarding cocaines potential toxicity and alternative medications are continuously sought after
A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor
The investigators wish to compare the analgesic effects of cocaine and lidocainephenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers
For these awake patients extra precautions must be taken to ensure the procedure is conducted with minimal pain and discomfort The pain and discomfort arises from the mechanical manipulation of the nasal mucosa and can be alleviated in part by means of topical analgesia as well as through decongestion providing more space within the nasal cavity For these purposes several drugs in varying combinations and dosages are used but no single drug choice is universally recommended
Cocaine is one of these appropriate drugs It is a magistral formula used especially due to its unique combination of both vasoconstrictive and analgesic properties Concerns have though been raised regarding cocaines potential toxicity and alternative medications are continuously sought after
A combination of lidocaine and xylometazoline can also be used for preparation of the nose prior to awake nasal fiberoptic intubation Lidocaine contributes with its analgesic effect whilst xylometazoline functions as the vasoconstrictor
The investigators wish to compare the analgesic effects of cocaine and lidocainephenylephrine to each other and saline when subjectively scored on a visual analogue scale of 0-100 mm immediately after simulated awake nasal intubation on healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None