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Comparison of Diclofenacsodium and Paracetamol for Acute postcraniotomy pain in patients undergoing supratentorial tumour surgery

Comparison of Diclofenac sodium and Paracetamol for acute post craniotomy pain in patients undergoing supratentorial tumour surgery: a prospective randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018690
Enrollment
102
Registered
2019-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Diclofenac sodium: Analgesic efficacy of Paracetamol will be compared with Diclofenac sodium and need for rescue analgesia will be studied and rate of hematoma formation and platelet dy

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo elective craniotomy for supratentorial tumours; ASA 1&2 patients; age 18-65 years of age

Exclusion criteria

Exclusion criteria: Pregnant/nursing women, BMI >35kg/m2; patients with difficult airway, H/O CHF, liver & kidney diseases, COPD, patients with poor GCS & severely raised ICP, Patient refusal, patients requiring >24hours postoperative mechanical ventilation and unable to communicate postoperatively

Design outcomes

Primary

MeasureTime frame
To compare analgesic efficacy of diclofenacsodium sodium and paracetamol within first 48hours after supratentorial craniotomyTimepoint: To compare analgesic efficacy of diclofenacsodium sodium and paracetamol within first 48hours after supratentorial craniotomy

Secondary

MeasureTime frame
Effect of paracetamol and diclofenacsodium on 1) need for rescue analgesia; 2) coagulation profile and platelet function,3) incidence of hem atoms formation/expansion, 4) incidence of PONV, 5)duration of postoperative hospital stay, 6) effect on LFT&RFTTimepoint: Assesed at 12hours 24 hours and at 48hours postoperatively

Countries

India

Contacts

Public ContactR Raj Kiran

Post graduate institute of medical education and research

dr.shivsoni@gmail.com9914208550

Outcome results

None listed

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