Effectiveness of Penthrox vs Placebo in Sinus Procedures, a Clinical Trial
ConditionChronic Rhinosinusitis (CRS)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSt. Paul's Hospital, Canada
About this trial
The goal of this randomized controlled trial is to evaluate the effectiveness of inhaled methoxyflurane (Penthrox) as an analgesic for patients undergoing minor rhinology and sinus procedures, specifically comparing it to a placebo control. The primary question the study aims to answer is:
Does methoxyflurane provide superior pain relief compared to placebo during minor sinus procedures, as measured by the Visual Analog Scale (VAS)? If there is a comparison group: Researchers will compare the effects of Penthrox to the placebo (saline + one drop of methoxyflurane) to see if it provides better pain relief, reduces anxiety, and leads to fewer complications, including bleeding.
Participants will be asked to:
Inhale 3 mL of Penthrox or placebo during their procedure. Complete a VAS scale to assess pain. Complete anxiety assessments pre- and post-operatively. Be monitored for complications such as bleeding and other adverse effects. This study will help determine the effectiveness of Penthrox as a non-invasive, quick-acting analgesic for minor sinus surgeries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 19 years or older
Scheduled for minor sinus surgery or coblation procedures
Disqualifiers
Cystic fibrosis
Systemic vasculitis or other bleeding disorders
History of renal failure or severe kidney disease
History of liver failure or severe liver disease
Trial design
Design model
Parallel
Treatments tested in this trial
Methoxyflurane - Penthrox
Drug3ml
Placebo
Other interventionsaline + one drop of methoxyflurane
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PenthroxActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS) for Pain
This scale measures the intensity of pain experienced by the participant during and immediately after the procedure. Participants will rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable) at various time points: immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure. The primary goal is to compare the pain relief provided by methoxyflurane (Penthrox) versus the placebo.
Time frame
Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.2
Pain Duration
This measure tracks the duration of pain experienced by the participant post-surgery. This will help assess how long the pain relief from methoxyflurane lasts compared to the placebo.
Time frame
It will be recorded as the time (in minutes or hours) from the end of the procedure until the participant reports no significant pain in a time frame of 4 hours3
Numeric Pain Rating Scale (NPRS)
The NPRS will be used as a secondary assessment to quantify the severity of pain. Patients will rate their pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The NPRS is a simpler and widely used scale for self-reported pain.
Time frame
Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.4
Amount of Local Anesthetic Injections
his outcome measures the total number of local anesthetic injections (e.g., lidocaine or bupivacaine) required during the procedure. Fewer injections may indicate better pain control with the study intervention (methoxyflurane) as compared to the placebo. This will help assess the need for additional pain management during surgery.
Time frame
Immediately post-procedure, 1 hour post-procedure, and at 24 hours post-procedure.Secondary outcomes
1
Type of Procedure
This measure records the specific type of minor sinus procedure the participant undergoes (e.g., coblation procedure or sinus surgery). This is important because different procedures may have varying levels of pain and complication risk, and it allows the study to analyze if the effectiveness of methoxyflurane varies based on the type of procedure.
Time frame
At surgery time2
Field of View During Surgery
The field of view refers to the surgeon's ability to see and access the surgical site during the procedure, which could be affected by pain, swelling, or bleeding. This will be assessed by the surgeon and recorded for both treatment groups to help determine if methoxyflurane has an impact on the ease or quality of the procedure.
Time frame
At surgery time3
Estimated Blood Loss in milliliters
This outcome measures the amount of blood lost during the procedure. It's particularly relevant for sinus surgeries, as excessive bleeding can affect the success of the surgery and recovery. Lower blood loss may be associated with better procedural conditions, potentially influenced by the use of methoxyflurane for pain management and sedation.
Time frame
At surgery time4
SNOT-22 Score
The SNOT-22 (Sinusitis Symptom Scale) is a widely used questionnaire assessing the severity of sinus-related symptoms, such as nasal congestion, facial pain, loss of smell, and overall quality of life.
Time frame
It will be administered pre-operatively, as well as at 4, 8, and 12 weeks post-opSponsors and contacts
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Source ClinicalTrials.gov