Rapid Administration of Methoxyflurane to patients in Emergency Department (ED) Study (RAMPED)

Phase 4

Completed

• Conditions: Pain; Emergency medicine - Other emergency care

• Registration Number: ACTRN12620000042943
• Lead Sponsor: Medical Developments International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-16
• Study Start: 2020-01-21
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

- Adult patients (aged greater than or equal to 18 years, and less than or equal to 75 years)
- Presentation to ED from home or scene of incident
- Initial pain score of 8/10 or greater

Exclusion Criteria

- Interhospital transfers
- Haemodynamic instability (cardiovascular instability, respiratory depression, head injury or impaired conscious state) defined as vital sign measurements that would be within met call criteria (e.g. HR<40 or >140, SBP<90 or >180, RR< 6 or >36, GCS<14)
- Pain possibly due to acute coronary syndrome
- Patients presenting with headache
- Pregnant patients or patients currently breastfeeding
- Known renal/hepatic failure
- Hypersensitivity to fluorinated anaesthetics
- Malignant hyperthermia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be defined as the proportion of participants achieving significant pain reduction, as assessed by a patient reported score via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. [30 minutes since time of administration]