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Intravenous Paracetamol for Peri-operative Shivering Prophylaxis after Spinal Anesthesia in Lower Abdominal and Lower Extremities Surgery : A Randomized Controlled Trial

Intravenous Paracetamol for Perioperative Shivering Prophylaxis after Spinal Anesthesia in Lower Abdominal and Lower Extremities Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210209004
Enrollment
92
Registered
2021-02-09
Start date
2021-02-15
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

paracetamol acetaminophen shivering shivering prophylaxis spinal anesthesia lower abdominal surgery lower extremities surgery paracetamol acetaminophen shivering shivering prophylaxis perioperative shivering spinal anesthesia lower abdominal surgery lower extremities surgery

Interventions

paracetamol 1 g. iv drip over 15 minutes before spinal anesthesia ,normal saline iv drip over 15 minutes before spinal anesthesia
Active Comparator Drug,Placebo Comparator No treatment
intravenous paracetamol,placebo

Sponsors

Faculty of Medicine, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 18 - 70 years old, ASA physical status 1 - 3, planned surgery under spinal anesthesia, expected duration of surgery less than 4 hours

Exclusion criteria

Exclusion criteria: refuse to participate in the study, pregnancy, liver disease such as cirrhosis and elevated AST or ALT above three times baseline or alcohol abuse, renal disease such as GFR less than 30 ml/min, asthma, baseline body temperature above 37.8 or below 36 degree celsius before surgery, received paracetamol within 6 hours before surgery, received tramadol within 6 hours or pethidine within 4 hours before surgery, history of chronic use of NSAIDs for more than 2 weeks, uroscopy procedure, neurological disease such as Parkinson disease, paracetamol allergy or contraindication of paracetamol

Design outcomes

Primary

MeasureTime frame
incidence of shivering after spinal anesthesia until 1 hour after the end of surgery shivering score

Secondary

MeasureTime frame
shivering score after spinal anesthesia until 1 hour after the end of surgery shivering score,body temperature after spinal anesthesia until 1 hour after the end of surgery tympanic temperature ,incidence of hypothermia after spinal anesthesia until 1 hour after the end of surgery tympanic membrane temperature ,perioperative morphine use after spinal anesthesia until 1 hour after the end of surgery total perioperative morphine consumption,total dose of perioperative pethidine after spinal anesthesia until 1 hour after the end of surgery total dose of perioperative pethidine ,PONV after spinal anesthesia until 1 hour after the end of surgery incidence of PONV,complication after spinal anesthesia until 1 hour after the end of surgery complication

Countries

Thailand

Contacts

Public ContactDonlaya Srikajonkiat

Faculty of Medicine, Khon Kaen University

s.donlaya@kkumail.com0831473340

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026