Objectives: To investigate the efficacy of Intramuscular haloperidol plus midazolam as co-analgesics among opium dependent patients in the emergency department.
Design: Double-blind, randomized, placebo-controlled trial.
Setting and conduct: From September 2011 to September 2012, participants were randomly assigned in either group A or B. A nurse who was blinded to the participants was administered the drugs.
Participants, including major eligibility criteria: Adult (18 years and older) patients who were opium dependent and had been admitted to the emergency department because of pain.
Exclusion criteria: Age below 18 years; refuse to participation in the trial; inability to express or evaluate the pain (loss of consciousness, non-verbal patients due to articulation problems or mental decline); systolic blood pressure under 100 mm Hg; long QT interval in electrocardiogram and pregnancy.
Intervention: Group A received morphine 0.05 mg/kg intravenously (IV) and a mixture of midazolam 2.5 mg and haloperidol 2.5 mg [diluted in 5 cc of distilled water, intramuscular (IM)]; group B received morphine 0.05 mg/kg IV and distilled water 5 cc, IM.
Main outcome measures: 1. Pain intensity based on numeric rating scale from 0 to 10, before and 1, 3 and 6 hours following intervention 2. Total doses of morphine, administered in case of inadequate pain control, 3. Hemodynamic status and level of consciousness of participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041219971N2
Registration date:2016-05-14, 1395/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-14, 1395/02/25
Registrant information
Name
Ehsan Karimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3600
Email address
e-karimi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Does midazolam plus haloperidol enhance morphine analgesia in opium dependent patients?
A randomized clinical trial
Public title
Does midazolam plus haloperidol enhance morphine effect in opium dependent patients?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adult (18 years and older) patients who were opium dependent and had been admitted to the emergency department because of pain.
Exclusion criteria: Age below 18 years; refuse to participation in the trial; inability to express or evaluate the pain (loss of consciousness, non-verbal patients due to articulation problems or mental decline); systolic blood pressure under 100 mm Hg; long QT interval in electrocardiogram and pregnancy.
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poorsina Avenue, Keshavarz Boulevard.
City
Tehran
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
1137435
Health conditions studied
1
Description of health condition studied
Opium dependence syndrome
ICD-10 code
F11.2
ICD-10 code description
Mental and behavioral disorders due to use of opioids : dependence syndrome
Primary outcomes
1
Description
Pain intensity
Timepoint
Pre-intervention and at 1,3,6 hours post intervention
Method of measurement
Numerical Rating Scale
2
Description
Morphine doses
Timepoint
1,3 and 6 hours post-intervention
Method of measurement
Total doses of morphine (mg)
Secondary outcomes
1
Description
Side effects
Timepoint
1,3and 6 hours post intervention
Method of measurement
Observation and clinical examination
Intervention groups
1
Description
Controls were received intravenous morphine 0.05 mg/kg and 5 cc of intramuscular distilled water.
Category
Treatment - Drugs
2
Description
Cases were received intravenous morphine 0.05 mg/kg and intramuscular mixture of haloperidol 2.5 mg plus midazolam2.5 mg diluted in 5 cc of distilled water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Afzalimoghadam
Street address
Shahid Chamran highway, Bagherkhan avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Afzalimoghadam
Street address
Poorsina Avenue, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical Sciences
Full name of responsible person
Mohammad Afzalimoghadam
Position
Associate Professor of Emergency Medicine
Other areas of specialty/work
Street address
Poorsina Avenue, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
afzalimoghadam@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimialavijeh
Position
Assistant professor of Emergency Medicine
Other areas of specialty/work
Street address
Poorsina Avenue, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
e-karimi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimialavijeh
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Poorsina Avenue, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
e-karimi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)