Clinical trial NCT03868436: PENTHROX™ in the Canadian Emergency Department (ED)
Official title: A Phase IV Real World Study on the Use of Low Dose Methoxyflurane (PENTHROX™) for the Treatment of Moderate to Severe Trauma Pain in the Canadian Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Lead sponsor: Purdue Pharma, Canada
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.

Detailed description: The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.

Eligibility criteria: Inclusion Criteria:

1. Conscious adult patients: ≥ 18 years of age
2. Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as

   * Musculoskeletal injuries and physical wounds
   * Fractures
   * Lacerations
   * Burns
   * Dislocations
   * Contusions
   * Injury due to foreign bodies
3. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

1. Multi-level trauma
2. Women of child bearing potential who are pregnant or peri partum, including labour
3. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
4. Clinically significant renal impairment
5. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
6. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
7. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
8. Exacerbation of an underlying condition (i.e., chronic pain)
9. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
10. Clinically evident respiratory impairment as per the opinion of the investigator
11. Prior treatment with PENTHROX within 3 months

Primary outcomes:
measure: Change in mean pain intensity: Numerical Rating Scale
timeFrame: 20 mins from start of administration (STA) of PENTHROX™
Secondary outcomes:
measure: Speed of action of analgesia
timeFrame: At any point from STA of PENTHROX™ to 20 mins post inhalation
measure: Proportion of treatment-emergent adverse events (TEAEs)
timeFrame: At any point From STA of PENTHROX™ until the end of the observation period (24 hours)
measure: Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional)
timeFrame: at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours)
measure: Fulfillment of pain relief expectations (Patient & Healthcare professional)
timeFrame: At the end of the observation period (up to 24hours)
measure: Use of rescue medication
timeFrame: From STA of PENTHROX™ to the end of the observation period (up to 24hours)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Charles V Keating Emergency and Trauma Centre, QEII
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville
state: Ontario
city: Welland
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Chicoutimi
country: Canada
facility: Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean
state: Quebec
city: Greenfield Park
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
state: Quebec
Study officials:
affiliation: Purdue Pharma, Canada
name: Sonja Dhani, PhD
role: STUDY_DIRECTOR
References: