Determination of equal analgesic doses between inhaled metoxyflurane and intravenous fentanyl using ice-water test in volunteers.

Determination of analgesic equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl using cold pressor test (CPT) in volunteers: A randomized, double blind, placebo-controlled crossover study. - metoxyflurane vs. fentanyl

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003939-30-NO

Enrollment

Registered

2018-12-12

Start date

2019-02-08

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

Experimental pain model (cold pressor test – CPT) will be used to determinate equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.

Interventions

Trade Name: Penthrox 3 ml® Pharmaceutical Form: Inhalation vapour, liquid Pharmaceutical form of the placebo: Concentrate for solution for injection Route of administration of the placebo: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The volunteers should be in good health and not have any chronic illness. 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: No use of pain medication and complementary medicine the last 2 days before a session. Previous substance abuse, pregnancy and known allergies or serious side effects to opioids or metoxyflurane.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to determinate equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.;Secondary Objective: The aim of this study is to determinate equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.;Primary end point(s): Painscores (NRS – numeric rating scores, 0 -10) during CPT for the different treatments will be compared. ;Timepoint(s) of evaluation of this end point: NRS (numeric rating scale, 0-10) scores during CPT 5 minutes after drug administration.	—

Measure

Time frame

Main Objective: The aim of this study is to determinate equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.;Secondary Objective: The aim of this study is to determinate equipotent doses of inhaled metoxyflurane vs. intravenous fentanyl.;Primary end point(s): Painscores (NRS – numeric rating scores, 0 -10) during CPT for the different treatments will be compared. ;Timepoint(s) of evaluation of this end point: NRS (numeric rating scale, 0-10) scores during CPT 5 minutes after drug administration.

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Secondary

Measure	Time frame
Secondary end point(s): NRS scores during CPT 20 minutes after drug administration.;Timepoint(s) of evaluation of this end point: NRS scores during CPT 20 minutes after drug administration	—

Countries

Norway

Contacts

Public ContactDepartment of anaesthesiology

Oslo University Hospital

harald.lenz@medisin.uio.no004723070000

Outcome results

None listed

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