A study to evaluate the effect of early versus late paracetamol administration on postoperative shivering

To evaluate the effect of early versus late paracetamol administration on postoperative shivering and pain scores after general anaesthesia- A prospective randomized double blind clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074401

Enrollment

174

Registered

2024-09-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Early Paracetamol group: IV PCM 15 mg/kg (maximum 1 g) over 20 min immediately after anaesthesia induction Intervention2: Late Paracetamol group: IV PCM 15 mg/kg (maximum 1 g) for 20 mi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective surgery under general anesthesia 2.Age 18-65 years 3.Either gender 4.American Society of Anaesthesiologists (ASA) physical status classification system I/II 5.Expected duration of surgery 1- 4 h.

Exclusion criteria

Exclusion criteria: 1.Patient refusal 2.BMI more than 40 kg/cm2 3. Known allergy to paracetamol or contraindications to its use 4.Pre-operative and intraoperative body temperature more than 38°C or less than 36°C 5.Patients having history of seizures, thyroid or hepatic disorder.

Design outcomes

Primary

Measure	Time frame
To compare the proportion of patients developing postoperative shivering till 4 hours postoperatively after intraoperative administration of early and late paracetamol.Timepoint: Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively	—

Secondary

Measure	Time frame
1. To assess and compare the severity of shivering in patients developing POS. 2. To observe the pain scores and time to analgesic requirement in the postoperative period with early and late PCM administration while minimizing the effect of intraoperative opioids on postoperative pain scores. 3. To compare the proportion of patients developing postoperative hypothermia after early and late PCM administration while maintaining intraoperative normothermia.Timepoint: Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively	—

Measure

Time frame

1. To assess and compare the severity of shivering in patients developing POS. 2. To observe the pain scores and time to analgesic requirement in the postoperative period with early and late PCM administration while minimizing the effect of intraoperative opioids on postoperative pain scores. 3. To compare the proportion of patients developing postoperative hypothermia after early and late PCM administration while maintaining intraoperative normothermia.Timepoint: Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively

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Countries

India

Contacts

Public ContactDr Kriti Chaudhary

AIl India Institute of Medical Sciences, Rajkot, Gujarat

kritisms@gmail.com9785036006

Outcome results

None listed

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