To evaluate the safety and efficacy of Penthrox® (methoxyflurane) for the treatment of pain during colonoscopy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Referred for colonoscopy for clinical indications or cancer screening
2.Males and females, age = 18 years.
3.Female Subjects less than one year post-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, and be non-lactating.
4.Written informed consent obtained from the Subject indicating that they understand the purpose of, and procedures required, for the study and are willing to participate in it.
5.Ability to understand the use of the Penthrox (Methoxyflurane) inhaler.

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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1.Pregnancy or lactation period (women only)
2.Previous colorectal resections
3.Same-day bi-directional endoscopy
4.Subjects having a pain score (pain right now) > 2 as assessed by a NRS score (0 – 10) at baseline
5.Subjects with any condition e.g. extreme anxiety judged by the Investigator to interfere with correct administration of Penthrox (Methoxyflurane) inhaler
6.Diagnosed anxiety disorders
7.Concomitant treatment with psychotropic drugs including benzodiazepines
8.Active alcohol or drug abuse and/or history of opioid abuse
9.Renal impairment defined as creatinine >1.5 x ULN measured at screening
10.Subjects taking any potential nephrotoxic drugs (e.g. aminoglycosides)
11.Uncontrolled diabetes mellitus as evidenced by HbA1c > 8% at screening or known diabetic nephropathy
12.Evidence of clinically significant disease e.g. liver, cardiac, respiratory or malignant disease (e.g., ischemic heart disease, chronic obstructive pulmonary disease, chronic liver disease) based on Investigator assessment of medical notes and/or subject recall, physical examination, laboratory and ECG assessments conducted at screening with ASA 3 or higher
13.Previous possible allergy to the study medication by the subject or relative
14.Any history of hypersensitivity to fluorinated agents
15.Concomitant head injury
16.Unconsciousness
17.Personal or family history of malignant hyperthermia
18.Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
19.Subjects who are incapable of giving informed consent or complying with the protocol.
20.Subjects who have a history of showing signs of liver or kidney damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia.
21.Requiring treatment with any prohibited concomitant medications
22.Use of any premedication before the procedure e.g. with sedative or analgesic medications within 24 hours before colonoscopy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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