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Comparison of analgesia between intravenous paracetamol and intranasal tapentadol in open cholecystectomy patients.

Postoperative analgesia between intravenous paracetamol VS intranasal tapentadol in open cholecystectomy patients: A non-inferiority clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072667
Enrollment
150
Registered
2024-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: K803- Calculus of bile duct with cholangitis Health Condition 2: K804- Calculus of bile duct with cholecystitis Health Condition 3: K801- Calculus of gallbladder with othercholecystitis Health Condition 4: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: tapentadol: tapentadol will be given intranasally 45 mg (22.5 mg each nostril ) 8 hourly for 24 hour Control Intervention1: Paracetamol: IV paracetamol 1 gm infusion 8 hourly for 24 hou

Sponsors

prajnaparmita saha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the newly diagnosed cholecystitis patients undergoing open cholecystectomy with ASA 1 & 2 at general surgery dept. of AGMC in the age group of 18 yrs and above.

Exclusion criteria

Exclusion criteria: 1.Patients with ASA Grade III or above. 2.Patients on immunosuppressive drugs. 3.Paitents unwilling for giving consent 4.Pregnant and lactating Women.

Design outcomes

Primary

MeasureTime frame
Degree of analgesia by VAS scoreTimepoint: 2 hour after delivery of each analgesic dose.last analgesic dose will be administered 24 hours after cholecystectomy. Final outcome ( VAS score) will be assessed 2 hours after last analgesic dose that is 26 hours after cholecystectomy

Secondary

MeasureTime frame
Adverse effects of intranasal tapentadol & intravenous paracetamolTimepoint: 2 hours after administration of each drug dose. patients will be assessed for 24 hours after cholecystectomy

Countries

India

Contacts

Public ContactPrajnaparmita Saha

Guide

contactdebasisray@gmail.com9436125100

Outcome results

None listed

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