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Trial record 79 of 448 for:    diphenhydramine

TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (TREC)

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ClinicalTrials.gov Identifier: NCT03639558
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
University of Nottingham
Hopital Psychiatrique De La Croix
Information provided by (Responsible Party):
Joseph Dib, Hopital Psychiatrique De La Croix

Brief Summary:
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

Condition or disease Intervention/treatment Phase
Psychiatric Emergency Aggression Agitation Drug: Haloperidol + Promethazine + Chlorpromazine Drug: Haloperidol + Promethazine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Actual Study Start Date : August 28, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 7, 2019


Arm Intervention/treatment
Active Comparator: Haloperidol + Promethazine + Chlorpromazine Drug: Haloperidol + Promethazine + Chlorpromazine
This is the usual treatment given by this hospital during an aggressive psychiatric episode.

Experimental: Haloperidol + Promethazine Drug: Haloperidol + Promethazine
This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.




Primary Outcome Measures :
  1. Assessing change of patient's aggressive behavior to calm and tranquil. [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]
    Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.


Secondary Outcome Measures :
  1. Time taken for patient to fall Asleep [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]
    Patient has fallen asleep and is no longer aggressive post intervention treatment and will be noted on the outcomes form which includes a checklist of different time intervals: 20, 40, 60 and 120 minutes post intervention treatment.

  2. Time patient was placed in Straitjacket/Restraint post intervention treatment [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]
    If patient was placed in a straitjacket post intervention due to aggression - this would be noted on the outcomes form which includes a checklist at certain time intervals 20,40,60 and 120 minutes post intervention treatment.

  3. Time noted where Important Adverse Effects occurred post intervention [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]
    If patient exhibits any adverse effects post intervention treatment, it would be noted on the outcomes form either at 20,40, 60 or 120 minutes post intervention.

  4. Time patient left the ward against medical advice during the time period after the intervention was administered. [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]
    If patient had to leave ward against medical advice during intervention phase



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
  • Gender - both male and female
  • Age (18-64)
  • Clinician is unaware on the effects of either treatment interventions

Exclusion Criteria:

  • If the clinician KNOWS one treatment has benefit over another for a particular person
  • If the clinician is aware of a contra-indication of one of the treatments
  • If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
  • If the clinician does not want to undertake for both personal and professional reasons.
  • If the participant is known to be allergic to one or more of the interventions
  • Already randomized
  • Already sedated
  • Accompanying person (Friend/Family/Police Officer) refuses patient trial entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639558


Locations
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Lebanon
Hôpital Psychiatrique De La Croix
Beirut, Jal L Dib, Lebanon
Psychiatric Hospital of the Cross
Beirut, Lebanon
Sponsors and Collaborators
Joseph Dib
University of Nottingham
Hopital Psychiatrique De La Croix

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Responsible Party: Joseph Dib, Director of Trial Research, Hopital Psychiatrique De La Croix
ClinicalTrials.gov Identifier: NCT03639558     History of Changes
Other Study ID Numbers: DPAP - 2018 - 0138 - 1
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Emergencies
Aggression
Disease Attributes
Pathologic Processes
Behavioral Symptoms
Haloperidol
Chlorpromazine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents