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Effect of adding sedative agent to analgesics for headache treatment

The Effect of Adding Intravenous Midazolam to Apotel®in Treatment of Patients with Primary Headache Referred to Emergency Department

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016013112592N3
Enrollment
120
Registered
2016-08-18
Start date
2016-03-20
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

Headache. migraine and other headache syndromes

Interventions

Intervention 1: Intervention group 1: In this group, Midazolam (1cc, 5 mg, Darou pakhsh, Tehran, IR Iran) 0.02 mg/kg plus Apotel (1 gr, 6.7 cc, cobel darou, Tehran, IR Iran) 15 mg/kg (up to 1 gr) will
Treatment - Drugs
Intervention group 1: In this group, Midazolam (1cc, 5 mg, Darou pakhsh, Tehran, IR Iran) 0.02 mg/kg plus Apotel (1 gr, 6.7 cc, cobel darou, Tehran, IR Iran) 15 mg/kg (up to 1 gr) will be used intrave
Intervention group 2: In this group, Apotel (1 gr, 6.7 cc, cobel darou, Tehran, IR Iran) 15 mg/kg (up to 1 gr) will be used intravenously.

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: All 18-65 years old patients with primary headache (Migraine or tension). Exclusion criteria: Sensitivity to used medicine, secondary type headache, vomiting, pregnancy, loss of consciousness, hepatic failure, breast-feeding, renal failure, psychotic disorder, get a medicine before arriving to emergency ward, dissatisfaction to participate to study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration of pain relief. Timepoint: The time between medicine prescription and pain releif. Method of measurement: With stopwatch.

Secondary

MeasureTime frame
Patient satisfaction. Timepoint: After the end of treatment, we will ask from patient about satisfaction of treatment. Method of measurement: Visual Analog Scale. This scale contains 1-10 scores that score 1 shows dissatisfaction and score 10 show excellent satisfaction.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Rahmani

Tabriz University of Medical Sciences

rahmanif@tbzmed.ac.ir+98 41 3549 8144

Outcome results

None listed

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