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

Primary Purpose

Acute Pain Due to Trauma

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Methoxyflurane

About this trial

This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring Pain, Trauma, Analgesia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Barnsley District General Hospital
Birmingham Children's Hospital NHS Foundation Trust
Colchester General Hospital
James Cook University Hospital
Royal Victoria Infirmary
Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methoxyflurane

Normal Saline

Arm Description

Outcomes

Primary Outcome Measures

VAS Score

The difference between treatment and placebo on the VAS pain score

Secondary Outcome Measures

Rescue Medication

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

The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.

Responder analysis

The number of responders will be defined

Safety Analysis

Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge

Full Information

NCT ID

NCT01420159

First Posted

August 11, 2011

Last Updated

October 30, 2012

Sponsor

Medical Developments International Limited

Collaborators

ORION Clinical Services

1. Study Identification

Unique Protocol Identification Number

NCT01420159

Brief Title

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

Acronym

STOP!

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 Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical Developments International Limited

Collaborators

ORION Clinical Services

4. Oversight

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain Due to Trauma

Keywords

Pain, Trauma, Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methoxyflurane

Arm Type

Experimental

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Methoxyflurane

Other Intervention Name(s)

Penthrox

Intervention Description

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

Primary Outcome Measure Information:

Title

VAS Score

Description

The difference between treatment and placebo on the VAS pain score

Time Frame

Twenty Minutes

Secondary Outcome Measure Information:

Title

Rescue Medication

Description

A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured

Time Frame

Up to a maximum of 6 hours

Title

Time to pain relief

Description

The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.

Time Frame

Up to a maximum of 6 hours

Title

Responder analysis

Description

The number of responders will be defined

Time Frame

Up to a maximum of 6 hours

Title

Safety Analysis

Description

Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge

Time Frame

Up to 16 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank M Coffey

Organizational Affiliation

Nottingham University Hospitals, Queen's Medical Centre Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barnsley District General Hospital

City

Barnsley

ZIP/Postal Code

S75 2EP

Country

United Kingdom

Facility Name

Birmingham Children's Hospital NHS Foundation Trust

City

Birmingham

ZIP/Postal Code

B4 6NH

Country

United Kingdom

Facility Name

Colchester General Hospital

City

Colchester

ZIP/Postal Code

CO4 5JL

Country

United Kingdom

Facility Name

James Cook University Hospital

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Royal Victoria Infirmary

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30863141

Citation

Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019.

Results Reference

derived

PubMed Identifier

27567918

Citation

Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.

Results Reference

derived

PubMed Identifier

24743584

Citation

Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.

Results Reference

derived

Learn more about this trial

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

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