Xylometazoline and Cocaine for Nasal Vasoconstriction

NCT05334017 | Completed Phase 4

• 3 other identifiers: 893032002021-000691-11H-21028051
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epistaxis

Keywords

nasal intubation; vasoconstriction; epistaxis

Outcome Measures

Primary Outcomes (1)

• Bleeding score

  Evaluation of epistaxis measured on a predefined scale of 0-3: 0\. No sign of bleeding 1. Blood only on the tracheal tube 2. Pooling of blood in the pharynx 3. Bleeding to the extent that it complicates intubation

  Immediately following nasal intubation

Secondary Outcomes (2)

• Qualitative measurements of cocaine's main metabolite benzoylecgonine in saliva

  Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.

• Quantitative measurements of cocaine in whole blood.

  Immediately prior to nasal intubation, 60 minutes after administration of cocaine and 24 hours after administration of cocaine.

Study Arms (2)

Xylometazoline

ACTIVE COMPARATOR

Xylometazoline 0,1% as nasal solution given immediately prior to nasal intubation

Drug: Xylometazoline 0,1%

Cocaine

ACTIVE COMPARATOR

Cocaine 4% as nasal solution given immediately prior to nasal intubation

Drug: Cocaine 4%

Interventions

Xylometazoline 0,1% DRUG

1 ml of 0,1% xylometazoline diluted with 1 ml of 0,9% isotonic saline solution given as a nasal spray

Also known as: Zymelin

Xylometazoline

Cocaine 4% DRUG

2 ml of 4% cocaine given as a nasal spray

Also known as: Cocaine hydrochloride 4%

Cocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Scheduled for nasal intubation
• Proficient in spoken and written Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Mo Haslund Larsen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: September 8, 2022
• Primary Completion: March 21, 2023
• Study Completion: March 22, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)