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Efficacy Prophylactic Rectal Diclofenac in Preventing Post-Anesthesia Shivering During Cesarean Section

Efficacy And Safety of Prophylactic Rectal Diclofenac in Preventing Post-Anesthesia Shivering During Cesarean Section: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241115063724N1
Enrollment
88
Registered
2024-12-31
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Post-cesarean section shivering is the involuntary shaking or shivering that happen due to several reasons, including the effects of anesthesia, a drop in body temperature during surgery, and the body's response to stress and changes in the blood flow following cesarean section.

Interventions

Intervention group: Receives 100mg rectal diclofenac suppository 10 minutes before surgery.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women aged 18-40 years Undergoing cesarean section ASA status I or II Willing to participate in the study

Exclusion criteria

Exclusion criteria: Allergy to diclofenac Cardiovascular disease Hypertension Diabetes Kidney disease Chronic lung disease Liver disease History of alcohol consumption Body temperature below 36°C Body temperature above 38°C

Design outcomes

Primary

MeasureTime frame
Comparison of Tsai and Chu scores between the intervention and placebo groups after cesarean section. Timepoint: Patients are observed at least for 30 minutes immediately after surgery while covered with a blanket and the shivering score will be recorded every 15 minutes until recovery from anesthesia. Method of measurement: Shivering assessment is done using the Tsai and Chu scale (0-4).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGolnaz Mesbah

Shahid Beheshti University of Medical Sciences

golnazmesbah@gmail.com+98 21 2271 4869

Outcome results

None listed

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