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Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma

Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201603089014N94
Enrollment
105
Registered
2016-03-27
Start date
2016-04-20
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Head trauma. Other and unspecified injuries of head

Interventions

Intervention 1: Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min. Intervention 2: Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min. Interve

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: age of 15 to 50 years; head trauma during 24 hours severity of headache equal to or greater than 4 based on VAS

Exclusion criteria

Exclusion criteria: Decreased consciousness Abnormal neurologic findings Hemorrhagic and pathologic findings in brain CT scan A history of hemorrhagic disorders or using anti-coagulant agents A history of chronic headaches Multiple trauma Asthma Addiction Pregnancy Renal failure, liver disease, cardiovascular diseases, pulmonary diseases

Design outcomes

Primary

MeasureTime frame
Measuring the severity of headache. Timepoint: before, and 15 and 30 min after intervention. Method of measurement: using visual analog scale (VAS).

Secondary

MeasureTime frame
Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching). Timepoint: 15 and 30 min after intervention. Method of measurement: by question.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Alireza Azimi Far

Besat Hospital

azimi_a1122@yahoo.com+98 81 3364 0030

Outcome results

None listed

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