AgitationPHASTNCT01501123
Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
A study testing Haloperidol and Midazolam in people with Agitation, run by Catholic Health East at 1 site in United States.
Trial summary
PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST) The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1 o The RASS is a well validated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Agitation
- What is being tested?
- Haloperidol and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age <18
- Pregnant
- Allergic to study medication
- Transport to hospital other than Mercy Fitzgerald Hospital
- Unable to reach medical command prior to giving medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Catholic Medical Center
Darby, Pennsylvania, 19023
About this study
Official title: Re-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)
- The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment
- The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1
- The RASS is a well validated standardized score to measure a patient's agitation
- The secondary outcomes are
- Time until RASS returns to 0 or 1 if RASS <0
- Need for additional sedation
- Adverse effects (need for intubation, arrhythmia)
- Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying haloperidol
- Identification of potential study patients will be per state protocols
- Exclusion Criteria for the study
- Age <18
- Pregnant
- Allergic to study medication
- Transport to hospital other than Mercy Fitzgerald Hospital
- Unable to reach medical command prior to giving medication
- When a paramedic identifies a possible study candidate, the paramedic will consult medical command to see if the patient is appropriate for the study
- If the medical command agrees the patient is appropriate for the study, patients will be randomized to
- Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)
- Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age ≥65)
- The RASS will be documented by the prehospital providers every 5 minutes until arrival at the hospital
- Once the patient arrives at the ED, the RASS will be documented in PICIS® by the emergency department nurse at the time of triage and at a minimum of hourly until the RASS =0 or 1 for 2 consecutive hours
- Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267) 205-6453
Read more
Richmond Agitation Sedation Scale
RASS RASS Description
- 4 Combative, violent, danger to staff
- 3 Pulls or removes tube(s) or catheters; aggressive
- 2 Frequent non-purposeful movement
- 1 Anxious, apprehensive, but not aggressive 0 Alert and calm
- 1 Awakens to voice (eye opening/contact) >10 sec
- 2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec
- 3 Moderate sedation, movement or eye opening. No eye contact
- 4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation
- 5 Unarousable, no response to voice or physical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
5mg IM
MidazolamDrug
IM midazolam
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Experimental | IM Haloperidol Receives: Drug: Haloperidol |
| IM Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sedation
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Isenberg, Catholic Health East
- Investigators
- Derek Isenberg, MD, Principal investigator, Mercy Catholic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501123
- Sponsor's protocol ID
- MCMC 2010-24
- Acronym
- PHAST
- Status last verified
- Jul 2019
- First submitted
- 27 Dec 2011
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient
- ClinicalTrials.gov ID
- NCT01501123
- Acronym / sponsor ID
- PHAST / MCMC 2010-24
- Conditions
- Agitation
- Keywords
- Time to sedation of agitated patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Catholic Health EastUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PREHOSPITAL AGITATION AND SEDATION TRIAL (PHAST)
- The goal of the PHAST is to demine whether haloperidol is superior to midazolam for the sedation of agitated patients in the prehospital environment
- The primary outcome is the time to a Richmond Agitation and Sedation Scale (RASS) ≤1
- The RASS is a well validated standardized score to measure a patient's agitation
- The secondary outcomes are
- Time until RASS returns to 0 or 1 if RASS <0
- Need for additional sedation
- Adverse effects (need for intubation, arrhythmia)
- Mercy EMS will be the only EMS agency in the Commonwealth of Pennsylvania carrying haloperidol
- Identification of potential study patients will be per state protocols
- Exclusion Criteria for the study
- Age <18
- Pregnant
- Allergic to study medication
- Transport to hospital other than Mercy Fitzgerald Hospital
- Unable to reach medical command prior to giving medication
- When a paramedic identifies a possible study candidate, the paramedic will consult medical command to see if the patient is appropriate for the study
- If the medical command agrees the patient is appropriate for the study, patients will be randomized to
- Odd days: Haloperidol 5mg IM (age <65) or haloperidol 2.5 mg IM (age ≥65)
- Even days: Midazolam 0.05 mg IM to maximum of 5mg IM (age <65) or maximum of 2.5mg (age ≥65)
- The RASS will be documented by the prehospital providers every 5 minutes until arrival at the hospital
- Once the patient arrives at the ED, the RASS will be documented in PICIS® by the emergency department nurse at the time of triage and at a minimum of hourly until the RASS =0 or 1 for 2 consecutive hours
- Questions may be directed to Dr. Isenberg at disenberg@mercyhealth.org or at (267) 205-6453
Richmond Agitation Sedation Scale
RASS RASS Description
- 4 Combative, violent, danger to staff
- 3 Pulls or removes tube(s) or catheters; aggressive
- 2 Frequent non-purposeful movement
- 1 Anxious, apprehensive, but not aggressive 0 Alert and calm
- 1 Awakens to voice (eye opening/contact) >10 sec
- 2 Light sedation, briefly awakens to voice (eye opening/contact) <10 sec
- 3 Moderate sedation, movement or eye opening. No eye contact
- 4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation
- 5 Unarousable, no response to voice or physical stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Experimental | Drug: HaloperidolIM Haloperidol |
| IM Midazolam | Active comparator | Drug: Midazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Age <18
- Pregnant
- Allergic to study medication
- Transport to hospital other than Mercy Fitzgerald Hospital
- Unable to reach medical command prior to giving medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol5mg IM | Drug | Haloperidol |
| MidazolamIM midazolam | Drug | IM Midazolam |
Primary outcome
Time to sedation
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Isenberg, MD principal investigator
Mercy Catholic Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haloperidol and Midazolam in people with Agitation, run by Catholic Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sedation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.