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Comparison of the Efficacy of Intravenous Paracetamol and Ondansetron for Prevention of Post-spinal Anesthesia Shivering Following Lower Abdominal and Lower Limb Surgeries in Buddhasothorn Hospital: A Phase II Prospective, Double-blind, Randomized Controlled Trial

Comparison of the Efficacy of Intravenous Paracetamol and Ondansetron for Prevention of Post-spinal Anesthesia Shivering Following Lower Abdominal and Lower Limb Surgeries in Buddhasothorn Hospital: A Phase II Prospective, Double-blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260114009
Enrollment
60
Registered
2026-01-14
Start date
2025-11-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Comparison of the Efficacy of Intravenous Paracetamol and Ondansetron for Prevention of Post-spinal Anesthesia Shivering Following Lower Abdominal and Lower Limb Surgeries Spinal anesthesia, shivering, paracetamol, ondansetron, lower abdomen surgery, lower extremity surgery

Interventions

Body weight more than or equal to 50 kg. receive Paracetamol 1000 mg. intravenous (infusion 30 minutes) after spinal anesthesia. If body weight less 50 kg. receive paracetamol 15 mg/kg.,Ondansetron 8
Active Comparator Drug,Experimental Drug
Paracetamol,Ondansetron

Sponsors

Buddhasothorn Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The American society of anesthesiologist (ASA) physical status 1 to 2 2. Preoperative Body Temperature 36.0 to 37.5 Celsius 3. Lower abdomen or lower extremity elective surgery with spinal anesthesia

Exclusion criteria

Exclusion criteria: 1. Contraindication for spinal anesthesia 2. Paracetamol and ondansetron allergy 3. Abnormal Preoperative body temperature 4. Shivering

Design outcomes

Primary

MeasureTime frame
Incident of shivering after spinal anesthesia Intraoperative and postoperative Shivering—

Secondary

MeasureTime frame
Level of Shivering after spinal anesthesia Intraoperative and postoperative Crossley and Mahajan scale,Adverse effect of paracetamol and ondansetron Intraoperative and postoperative Blood pressure, heart rate, Likert rating scale of nausea and vomitting—

Countries

Thailand

Contacts

Public ContactSupichaya Chairat

Buddhasothorn Hospital

Mimpurebear@gmail.com0894075455

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026