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Comparison of the Effect of Intravenous Paracetamol and Intrathecal Meperidine on Shivering After Spinal Anesthesia

A Comparative Study on the Effect of Intravenous Paracetamol and Intrathecal Meperidine on Shivering in Patients Undergoing Cesarean Section with Spinal Anesthesia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240221061070N5
Enrollment
90
Registered
2025-04-26
Start date
2025-04-28
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Shivering after Cesarean section under spinal anesthesia. Complication of anesthesia during labor and delivery, unspecified

Interventions

Intervention 1: Intervention group: In the intravenous paracetamol group, each patient will receive 1 gram of paracetamol diluted in 100 mL of normal saline, administered intravenously over 15 minutes

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for spinal anesthesia in elective cesarean section ASA class I and II Age between 18 and 45 years

Exclusion criteria

Exclusion criteria: Patients with systemic infections or infections at the site of spinal block Patients with thyroid disorders Patients with cardiovascular or pulmonary diseases Individuals with coagulation disorders Patients with neurological impairments Individuals with psychiatric disorders Patients with a known history of alcohol dependence or substance abuse Body Mass Index greater than 35 Baseline body temperature above 38°C or below 36.5°C, or those receiving vasodilator medications or drugs that interfere with thermoregulation Known history of hypersensitivity to paracetamol or meperidine

Design outcomes

Primary

MeasureTime frame
Incidence of shivering after spinal anesthesia. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Observation and patient inquiry.;Severity of shivering after spinal anesthesia. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Bedside Shivering Assessment Scale (BSAS).

Secondary

MeasureTime frame
Heart rate. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Vital signs monitoring device.;Central temperature. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Core temperature assessment using a standard tympanic thermometer through the external auditory canal.;Peripheral temperature. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Axillary temperature measurement using a standard mercury thermometer.;Level of sedation in patients following spinal anesthesia. Timepoint: Every 15 minutes from the initiation of spinal anesthesia up to 90 minutes post-procedure. Method of measurement: Richmond Agitation-Sedation Scale (RASS).;Patient satisfaction with the spinal anesthesia procedure. Timepoint: 90 minutes after the initiation of spinal anesthesia. Method of measurement: 7-point verbal Likert scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMilad Masaeli

Esfahan University of Medical Sciences

drmilmas@gmail.com+98 81 8485 3541

Outcome results

None listed

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