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Comparison of Oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate for acute pain in trauma patients

Comparison of oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate for acute pain management in trauma patients admitted to the emergency department of rasool Hospital, Tehran

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204298104N8
Enrollment
150
Registered
2012-05-06
Start date
2012-06-21
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

trauma. musculoskeletal sysytem and connective tissue diseases

Interventions

Intervention 1: Intervention group :administration of oxicodone 10mg/peroral and acetaminophen 1 gram intravenously and 5 cc streile waterintravenously as placebo and evaluation of pain score and sid
60 of study. Intervention 2: Control Group: Administration of 5 mg Morphine sulfate and oral placebo, after 0, 10, 30, 60 minutes pain score and side effects will be evaluated.
Treatment - Drugs
Intervention group :administration of oxicodone 10mg/peroral and acetaminophen 1 gram intravenously and 5 cc streile waterintravenously as placebo and evaluation of pain score and side effects in min
60 of study.
Control Group: Administration of 5 mg Morphine sulfate and oral placebo, after 0, 10, 30, 60 minutes pain score and side effects will be evaluated.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: signing informed consent by the participate in the study; age greater than 16 and less than 50 years old; moderate to severe pain caused by trauma (pain score above 5 on the visual Analog scale) and trauma to extremities without head trauma. Exclusion criteria: history of allergy or intolerance to morphine sulphate or oxycodone; concurrent substance abuse; mild to moderate pain (pain score of less than 5); psychiatric disorders; patients with history of chronic obstructive pulmonary disease, asthma, and ischemic heart disease; reduction in the patient's level of consciousness (GCS score less than 15 ); patients with low blood pressure (systolic blood pressure less than 90 mmHg); patients with liver dysfunction and pneumothorax.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain control. Timepoint: At the begining, 10, 30 and 60 minutes after the administration of the study medications. Method of measurement: Pain score by asking from patient.

Secondary

MeasureTime frame
Side effects and changes in vital signs. Timepoint: At the begining, 10, 30 and 60 minutes after the administration of the study medications. Method of measurement: Monitoring the patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Amin Zare

Tehran University of Medical Sciences

mazare74@yahoo.com+98 21 6652 5327

Outcome results

None listed

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