STOP!: Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma

Sponsor

Medical Developments International Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01420159

Collaborator

ORION Clinical Services (Industry)

300

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital Emergency Department with a minor injury (known as trauma).

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Due to Trauma	Drug: Methoxyflurane	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double Blind, Multi-centre, Placebo Controlled Study to Evaluate the Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Patients Presenting to an Emergency Department With Minor Trauma

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methoxyflurane	Drug: Methoxyflurane Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered. Other Names: Penthrox
Placebo Comparator: Normal Saline	Drug: Methoxyflurane Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered. Other Names: Penthrox

Arm

Intervention/Treatment

Experimental: Methoxyflurane

Drug: Methoxyflurane

Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.

Other Names:

Penthrox

Placebo Comparator: Normal Saline

Drug: Methoxyflurane

Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.

Other Names:

Penthrox

Outcome Measures

Primary Outcome Measures

VAS Score [Twenty Minutes]
The difference between treatment and placebo on the VAS pain score

Secondary Outcome Measures

Rescue Medication [Up to a maximum of 6 hours]
A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured
Time to pain relief [Up to a maximum of 6 hours]
The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.
Responder analysis [Up to a maximum of 6 hours]
The number of responders will be defined
Safety Analysis [Up to 16 days]
Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf.
Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.

Exclusion Criteria:

Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit.
Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
Unable to provide written informed consent.
Known pregnancy or lactation
Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
Treatment with any analgesic agent within 5 hours prior to presentation to ED (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ED).
Current ongoing use of analgesics for chronic pain.
Use of an investigational product within one month prior to presentation to ED.
Known personal or familial hypersensitivity to fluorinated anaesthetics.
Known personal or familial history of malignant hyperthermia.
Clinically significant respiratory depression.
Use of methoxyflurane in the previous 4 weeks.
Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician.
Clinically significant cardiovascular instability.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Barnsley District General Hospital	Barnsley	United Kingdom	S75 2EP
2	Birmingham Children's Hospital NHS Foundation Trust	Birmingham	United Kingdom	B4 6NH
3	Colchester General Hospital	Colchester	United Kingdom	CO4 5JL
4	James Cook University Hospital	Middlesbrough	United Kingdom	TS4 3BW
5	Royal Victoria Infirmary	Newcastle-upon-Tyne	United Kingdom	NE1 4LP
6	Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus	Nottingham	United Kingdom	NG7 2UH