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The benefit of using either nasal or oral preparation of Tapentadol during or after the operative procedure to decrease pain and control all other ill effects of pain.

Effectiveness of Tapentadol in perioperative analgesia : A prospective comparative study of nasal versus oral preparations.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040865
Enrollment
60
Registered
2022-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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: intranasal spray of Tapentadol Group N: 2 puffs of nasal Tapentadol 15 mins before induction of anaesthesia Control Intervention1: Tab Tapentadol 100mg 1 tablet per oral:Group T: Tab T

Sponsors

RKMSP VIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA Grade I and II 2.Elective laparoscopic cholecystectomies 3.Operations performed under general anaesthesia 4.Less than or equal to 120 mins duration

Exclusion criteria

Exclusion criteria: Body weight 60 kg Known hypersensitivity to any of the test drugs With coagulopathies or on anticoagulant On MAO inhibitors or SSRI sTaking opioid drugs or analgesic drugs Pregnant or lactating mothers Patient having atrophic rhinitis or nasal pathology R

Design outcomes

Primary

MeasureTime frame
Hemodynamic parameters including HR, SBP, DBP, MAP, RPP and any adverse effect will be recorded 1 min after intubation . Then the parameters will be recorded at intervals till the end of surgery. In the post operative period parameters will be recorded at 5mins, 120 mins, 240 mins after extubation. Timepoint: Hemodynamic parameters including HR, SBP, DBP, MAP, RPP and any adverse effect will be recorded 1 min after intubation . Then the parameters will be recorded at 15mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins,till the end of surgery. In the post operative period parameters will be recorded at 5mins, 120 mins, 240 mins after extubation.

Secondary

MeasureTime frame
VAS score ( Scale 1-10) will be recorded in the post operative period at intervals.Timepoint: VAS score ( Scale 1-10) will be recorded in the post operative period at 5mins, 120 mins, 240 mins after extubation.

Countries

India

Contacts

Public ContactDr Keya Chakraborty

RKMSP & VIMS Kolkata

drkeyachakraborty21@gmail.com9830183464

Outcome results

None listed

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