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Does midazolam plus haloperidol enhance morphine effect in opium dependent patients?

Does midazolam plus haloperidol enhance morphine analgesia in opium dependent patients? A randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016041219971N2
Enrollment
87
Registered
2016-05-14
Start date
2011-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opium dependence syndrome. Mental and behavioral disorders due to use of opioids : dependence syndrome

Interventions

Intervention 1: Controls were received intravenous morphine 0.05 mg/kg and 5 cc of intramuscular distilled water. Intervention 2: Cases were received intravenous morphine 0.05 mg/kg and intramuscular
Treatment - Drugs
Controls were received intravenous morphine 0.05 mg/kg and 5 cc of intramuscular distilled water.
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.

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 139 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Secondary

MeasureTime frame
Side effects. Timepoint: 1,3and 6 hours post intervention. Method of measurement: Observation and clinical examination.

Primary

MeasureTime frame
Pain intensity. Timepoint: Pre-intervention and at 1,3,6 hours post intervention. Method of measurement: Numerical Rating Scale.;Morphine doses. Timepoint: 1,3 and 6 hours post-intervention. Method of measurement: Total doses of morphine (mg).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Afzalimoghadam

Tehran university of medical Sciences

afzalimoghadam@sina.tums.ac.ir+98 21 6690 4848

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026