A randomised, double blinded, placebo controlled trial of the effect of self administered methoxyflurane using the Penthrox® Inhaler on tolerance of the Computed Tomography (CT) Enteroclysis procedure

For patients undergoing Computed Tomography (CT) Enteroclysis, self administered methoxyflurane via the Penthrox® inhaler may be better than placebo at improving patient tolerance of the procedure

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000058370

Acronym

Penthrox for CTE

Enrollment

Registered

2008-01-30

Start date

2008-01-02

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Methoxyflurane (Penthrox) is self administered by inhalation via the Penthrox Inhaler immediately before commencing the procedure. Patients can consume up to 1 vial (3 mL) of Penthrox.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Referred for CT enteroclysis Age 16 years or older Able to give written informed consent themselves

Exclusion criteria

Known pre-existing renal or hepatic impairment: serum creatinine = 1.5 x upper limit of normal range (ULNR) or bilirubin = 2 x upper limit of normal range (ULNR). Concomitant use of any of the following medications: tetracyclines, gentamicin, kanamycin, colistin, polymyxin b, cephaloridine or amphotericin b. Personal or familial hypersensitivity to fluorinated anaesthetics. Personal or familial malignant hyperthermia. Pre-medication with anxiolytic eg. midazolam, diazepam. Pre-medication with breakthrough dose of analgesic eg. paracetamol plus codeine or oxycodone. Hypotension pre-procedure: systolic blood pressure <90 mmHg. Bradycardia pre-procedure: heart rate <50 bpm. Poor oxygen saturation pre-procedure: O2 saturation <90%. Pregnancy: currently pregnant or attempting to become pregnant. Lactation: currently breastfeeding.

Outcome results