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effect of Midazolam prophylaxis on the seizures

Investigation of the effect of Midazolam prophylaxis on the incidence of idiosyncratic seizures caused by tramadol consumption

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180608040013N2
Enrollment
28
Registered
2020-04-22
Start date
2020-05-09
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Seizures. Conversion disorder with seizures or convulsions

Interventions

Intervention 1: Intervention group: Midazolam will be given an infusion at a dose of 0.05 mg / kg for 6 hours. Intervention 2: Control group: Normal saline will be given an infusion for 6 hours.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: Take tramadol tablets for the past 6 hours Age over 16 years No seizures before entering the study

Exclusion criteria

Exclusion criteria: Age over 70 years History of epilepsy Concomitant use of antidepressants Concomitant use of other drugs with a dose of poisoning History of underlying diseases Trauma to the head

Design outcomes

Primary

MeasureTime frame
Seizures. Timepoint: Up to 24 hours after hospitalization. Method of measurement: Based on the patient's records and interview with the patient in case of discharge before 24 hours.;Number of seizures. Timepoint: Up to 24 hours after hospitalization. Method of measurement: Based on the patient's records and interview with the patient in case of discharge before 24 hours.;The length of hospital stay. Timepoint: From hospitalization to discharge. Method of measurement: Based on patient records.;Need for mechanical ventilation. Timepoint: From hospitalization to discharge. Method of measurement: Based on patient records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNajmeh Zarei Jelyani

Shiraz University of Medical Sciences

n_zarei@sums.ac.ir+98 71 3630 2747

Outcome results

None listed

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