Pain control in opium dependent traumatic patients

Comparison analgesia effect of morphine and morphine plus low dose promethazine in opium dependent trauma patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014040717174N1

Enrollment

140

Registered

2014-08-15

Start date

2013-03-20

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

??Extremity Trauma. musculoskeletal system and connective tissue diseases

Interventions

Intervention 1: intervention group :administration of morphine 0.1 mg /kg and evaluation of pain score and side effects in minutes 0

120 of study. Intervention 2: control group :administration of morphine 0.1 mg/kg +12.5 mg of intravenous promethazine and evaluation of pain score and side effects in minutes 0

120 of study.

Treatment - Drugs

intervention group :administration of morphine 0.1 mg /kg and evaluation of pain score and side effects in minutes 0

control group :administration of morphine 0.1 mg/kg +12.5 mg of intravenous promethazine and evaluation of pain score and side effects in minutes 0

120 of study

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Age more than 18 years old; dependency to opium; fracture in upper or lower extremity; GCS=15; VAS=6 ; ability to talk; stable hemodynamic. Exclusion Criteria: Psychological disorder; analgesia administration before admission in Emergency department; chronic therapy with analgesic drugs; sensitivity to morphine or promethazine; unable to understand the VAS concept; pregnancy; necessity to nerve block; unwilling to take part in the intervention; refuse to continue the intervention; major trauma which is life threatening or causing defects; any history of chronic liver; kidney; lung; cardiac disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain Severity. Timepoint: 0, 10, 30, 60, 90 and 120 minutes after treatment. Method of measurement: Administration of Visual Analogue Scale and asking the patient to determine the severity of pain.	—

Secondary

Measure	Time frame
Side effects and changes in vital signs. Timepoint: 30 and 60 minutes after treatment. Method of measurement: Patient monitoring.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Abbasi, Medical Doctor

Iran University of Medical Sciences

saieedabbasi@yahoo.com+98 21 6535 2022

Outcome results

None listed

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