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The effect of intrathecal Midazolam in the severity of pain in Cesarean Section: A randomized controlled trial?

The effect of intrathecal Midazolam in the severity of pain in Cesarean Section: A randomized controlled trial?

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138807121310N4
Enrollment
124
Registered
2010-03-31
Start date
2007-12-10
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

Pain in caesarean section. Delivery by elective caesarean section

Interventions

Intervention 1: The intervention group(62 patients) will received Bupivacaine (12.5 mg) plus intrathecal Midazolam (0.13 mg/kg) intratechally. Intervention 2: Bupivacaine (12.5 mg) plus normal saline
Treatment - Drugs
Placebo
The intervention group(62 patients) will received Bupivacaine (12.5 mg) plus intrathecal Midazolam (0.13 mg/kg) intratechally.
Bupivacaine (12.5 mg) plus normal saline (0.5-1 ml) will used in control group (62 patients),intratechally.

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria included: No presence of severe spinal lesion, No presence of abscess or infection of skin and soft tissue in the location of needle insertion, No presence of sever anxiety and restlessness, No presence of Central Nervous System lesion, No presence of peripheral nerve lesion, No presence of significant mental disorders or drug abuse, Age 18-45 year. Exclusion criteria: severe spinal lesion, abscess or infection of skin and soft tissue in the location of needle insertion, sever anxiety and restlessness, Central Nervous System lesion, presence of peripheral nerve lesion, presence of significant mental disorders or drug abuse. Age less than 18 or more than 45 years old.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of pain. Timepoint: 5 min, 15 min, 30 min 1 hour, 2 hour and 4 hour aftercaesarean section. Method of measurement: Verbal Numerical Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli karbasfrushan, MD

Kermanshah University of Medical Sciences

ali_karbasfrushan@yahoo.com ? ?+98 918 137 0447

Outcome results

None listed

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