Comparison of xylometazoline vs. cocaine for prevention of nose bleeds upon intubation

Comparison of the effect of xylometazoline and cocaine on epistaxis when administered as local vasoconstrictors prior to nasal intubation

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000691-11-DK

Enrollment

Registered

2021-05-05

Start date

2022-01-18

Completion date

Unknown

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis upon nasal intubation

Interventions

Trade Name: Zymelin Pharmaceutical Form: INN or Proposed INN: XYLOMETAZOLINE CAS Number: 526-36-3 Product Name: Kokain øjendråber, opløsning, 40mg/ml (4%) Pharmaceutical Form: Nasal spray CAS Number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years • Scheduled for nasal intubation • Proficient in spoken and written Danish Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: • Intubation to be done on awake patient • Pregnancy in fertile women (Women under the age of 50 must produce a negative hCG urine stix to participate) • Known symptomatic coronary disease (As declared by patient or noted in the patient's file) • Uncontrolled hypertension (As declared by patient or noted in the patient's file + Not taking antihypertension drugs) • Closed-angle glaucoma

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Evaluation of epistaxis immediately following nasal intubation measured on a predefined score of 1-4.;Timepoint(s) of evaluation of this end point: Immediately following intubation	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Evaluation of epistaxis immediately following nasal intubation measured on a predefined score of 1-4.;Timepoint(s) of evaluation of this end point: Immediately following intubation

—

Secondary

Measure	Time frame
Secondary end point(s): Qualitative binary result of saliva analysis testing for cocaine (in cocaine group only) and Quantitative result of whole blood toxicology testing for cocaine (in cocaine group only);Timepoint(s) of evaluation of this end point: 1) On morning of operation 2) 60 minutes after cocaine administration 3) 24 hours after cocaine administration	—

Countries

Denmark

Contacts

Public ContactDepartment of Anesthesiology

Rigshospitalet, Centre of Head and Orthopaedics

anop-hoc.rigshospitalet@regionh.dk+4535453474

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026