RecruitingPhase 3ACTRN12613000709741

Patient-controlled analgesia with methoxyflurane (Penthrox inhaler) versus conventional endoscopist-provided sedation for colonoscopy: a randomized multi-centre trial

For Patients undergoing colonoscopy, will patient-controlled analgesia with methoxyflurane (Penthrox inhaler) versus conventional endoscopist-provided sedation for colonoscopy be as effective and safe in providing adequate analgesia.


Sponsor

Dr. Nam Q Nguyen

Enrollment

300 participants

Start Date

Jan 21, 2011

Study Type

Interventional

Conditions

Summary

The main aim is to investigate the efficacy and safety of methoxyflurane as a patient controlled analgesia in colonoscopic procedures, as compared to the traditional endoscopist provided analgesia/sedation. Hypothesis Methoxyflurane is as effective and safe in providing adequate analgesia for patients undergoing colonoscopic procedures as conventional intravenous sedative/analgesia with midazolam and fentanyl. Patients prefer patient controlled analgesia, compared with endoscopist administered analgesia.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of managing pain and discomfort during a colonoscopy procedure. One method uses a hand-held inhaler with a medication called methoxyflurane (Penthrox), which the patient controls themselves by breathing through the device. The other method uses the conventional approach where the doctor gives intravenous sedation (midazolam and fentanyl) through a drip. Researchers want to find out if patient-controlled inhalation is as effective and safe as doctor-administered sedation. You may be eligible if: - You are between 18 and 75 years old - You are scheduled for a colonoscopy - You are able to give informed consent - You can understand how to use the Penthrox inhaler You may NOT be eligible if: - You drink heavily (more than 40 g/day for men, 20 g/day for women) or use narcotics regularly - You have significant heart disease or chronic lung disease - You weigh less than 45 kg - You have diabetes, kidney problems, or a history of gastrointestinal surgery - You have had a previous head injury - You or a family member has a history of malignant hyperthermia - You do not read English Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Those randomised to the methoxyflurane arm will be given extra instructions on the use of the Penthrox inhaler. They will then be asked to inhale the methoxyflurane for approximately 2 minutes as a pr

Those randomised to the methoxyflurane arm will be given extra instructions on the use of the Penthrox inhaler. They will then be asked to inhale the methoxyflurane for approximately 2 minutes as a pre-medication from one, 3mL dose in a Penthrox inhaler. Since methoxyflurane has a sweet tasting smell, patients will be advised to breathe in a stepwise fashion (from shallow to deep) over that 2 minute period. Once the colonoscopy has commenced, patients will be encouraged to take an adequate inhalation of methoxyflurane to provide sufficient analgesia. Patients are then allowed to self administer as much methoxyflurane as they feel they require within the safety limit as recommended by the manufacturer (6mL /day). Furthermore, they will be instructed to self administer further doses of methoxyflurane by the endoscopist if the endoscopist anticipate potential loops which may cause discomfort.


Locations(3)

The Royal Adelaide Hospital - Adelaide

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

Lyell McEwin Hospital - Elizabeth Vale

SA, Australia

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ACTRN12613000709741