Health TrialsbyHealthPanel

Penthrox in Otolaryngology

ConditionAll Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital

About this trial

Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Skin lesion excision or reconstruction

Fine or core needle aspiration biopsy

Mucosal biopsy

Laryngeal injection or biopsy

Disqualifiers

Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)

Patients less than 18 years of age

Pregnancy, intended pregnancy, or current breast-feeding

Inadequate patient understanding or lack of cooperation

Trial population

All adult patients undergoing an otolaryngology proceure in the Otolaryngology clinic of the Jewish General Hospital with inhaled methoxyflurane as an adjunct to topical or local anesthesia

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Methoxyflurane anesthesia

    Drug

    A single Penthrox (3mL) self-inhaler will be administered 5-minutes prior to the onset of the procedure, before local anesthesia. Patients will undergo the procedure, have post-procedural vital signs, and remain in clinic for observation for 30 minutes post-procedure per our usual post-procedure monitoring.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients undergoing an otolaryngology in-office procedure using methoxyflurane1 intervention

Trial outcomes

Primary outcomes

1

TSQM-1.4 (Treatment Satisfaction Questionnaire for Medication 1.5)

This is a validated 14-item including Likert scales and dichotomous (yes/no) items on the effectiveness, side effects, convenience and global satisfaction with the medication taken

Time frame
At first follow-up visit (within 1 month post-procedure)

Secondary outcomes

1

Ability to complete intended procedure

Documented by clinic nurse post- procedure

Time frame
At procedure visit
2

Modified Ramsay Sedation score

Maximal sedation score during procedure documented by clinic nurse

Time frame
At procedure visit
3

Adverse events

Either self- or physician-reported

Time frame
At procedure visit and first follow-up visit (within 1 month post-procedure)
4

Visual analog pain scale

Maximal degree of pain during procedure

Time frame
At procedure visit

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Mortimer B. Davis - Jewish General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: