Comparison of intrathecal midazolam and tramadol in the control of pain and chills after cesarean section

Comparing the effect of adjuvant intrathecal midazolam and tramadol in the control of pain and shivering after spinal anesthesia in elective cesarean section

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012083010695N1

Enrollment

210

Registered

2013-02-06

Start date

2011-03-21

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

Elective cesarean section. Delivery by elective caesarean section

Interventions

Intervention 1: In the first group, to 75mg, 5% hyperbaric lidocaine , produced by Orion Pharaca Company, 2 mg midazolam, equal to 0.5 ml is added and is injected under sterile conditions using a

Treatment - Drugs

Placebo

In the first group, to 75mg, 5% hyperbaric lidocaine , produced by Orion Pharaca Company, 2 mg midazolam, equal to 0.5 ml is added and is injected under sterile conditions using a spinal needle n

In the first group, to 75mg, 5% hyperbaric lidocaine , produced by Orion Pharaca Company, 2 mg tramadol, equal to 0.5 ml is added and is injected under sterile conditions using a spinal needle no

In the third group, to 75mg, 5% hyperbaric lidocaine , produced by Orion Pharaca Company, 0.5 ml normal saline is added in order to equalize the volume with the two other groups and is injected

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria includes: Pregnant women with anesthesiologists class (ASA class) I, II ; age between 20-35 years old ; no chronic use of narcotics ; no history of heart or kidney diseases; no history of allergy or hypersensitivity to local anesthetics or narcotics and their consent to have spinal anesthesia. Exclusion criteria: patients in whom spinal anesthesia fails and we have to administer the general anesthesia and patients who are injected more than two times.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain intensity. Timepoint: In recovery and 4 ,12,24 hours after surgery. Method of measurement: Visual Analogue Scale.;Total administered analgesic. Timepoint: During the first 24 hours after surgery. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
The Chills. Timepoint: During the surgery, in recovery room, and four hours after surgery. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nasim Shahrokhi

Arak University of Medical Sciences

dr.shahrokhi@arakmu.ac.ir+98 86 1223 1103

Outcome results

None listed

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