Epistaxis Clinical Trial
Official title:
Comparison of the Effect of Xylometazoline and Cocaine on Epistaxis When Administered as Local Vasoconstrictors Prior to Nasal Intubation
Verified date | March 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to compare xylometazoline and cocaine's effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation. The investigators hypothesize that there will be a lower bleeding score in the group receiving xylometazoline as compared with the group receiving cocaine.
Status | Completed |
Enrollment | 120 |
Est. completion date | March 22, 2023 |
Est. primary completion date | March 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Scheduled for nasal intubation - Proficient in spoken and written Danish Exclusion Criteria: - Intubation to be done on awake patient - Pregnancy - Women of childbearing potential must produce a negative hCG urine stix to participate - Known symptomatic coronary artery disease - As declared by patient or noted in the patient's file - Untreated hypertension - As declared by patient or noted in the patient's file - Not taking antihypertension drugs - Hypersensitivity to the active substance or to any of the excipients of Zymelin - As declared by patient or noted in the patient's file - Closed-angle glaucoma - As declared by patient or noted in the patient's file |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding score | Evaluation of epistaxis measured on a predefined scale of 0-3:
0. No sign of bleeding Blood only on the tracheal tube Pooling of blood in the pharynx Bleeding to the extent that it complicates intubation |
Immediately following nasal intubation | |
Secondary | Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva | For cocaine-group only, saliva samples will be obtained and analyzed on the DrugTest 5000 machine used by the Danish Police Force in order to evaluate pharmacokinetics. | Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine. | |
Secondary | Quantitative measurements of cocaine in whole blood. | In the cocaine group only, blood samples will be drawn and analyzed for the presence of cocaine in order to evaluate pharmacokinetics. | Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine. |
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