Assessing the Quality of Recovery and requirement of pain receiving drug in patients receiving etoricoxib vs control group in mastoid surgery

Comparing Effects of Additional Preemptive Oral Etoricoxib with Placebo on Quality of recovery and Intraoperative Analgesic Consumption in Mastoid Surgery - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069208

Enrollment

Registered

2024-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: H709- Unspecified mastoiditis

Interventions

Intervention1: Tablet Etoricoxib: Tablet Etoricoxib 120 mg orally 30 minutes before induction Control Intervention1: Placebo: In Tablet form orally 30 minutes before induction

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age group 18 yrs to 60 yrs with ASA grading of I or II undergoing mastoid surgery and have given consent to participate in the study

Exclusion criteria

Exclusion criteria: Patient taking analgesics frequently or have any known allergy to NSAIDS or with any significant medical history of cardiac, hepatic or renal disease or have any history of Bleeding disorder or are suffering from severe hypovolemia, increased intracranial pressure, convulsion history and severe neurological deficit or are currently on chronic anticoagulant or anti-platelet therapy

Design outcomes

Primary

Measure	Time frame
1. Intraoperative Fentanyl consumption 2. Quality of Recovery-15 score (15 parameters each carrying score of 10) Timepoint: 1. Intraoperative Fentanyl consumption (according to hemodynamic changes intraoperatively. ) 2. Quality of Recovery-15 score of both groups 48 hrs post operatively	—

Secondary

Measure	Time frame
Difference in Visual Analog Score(VAS) of both groups at different time intervalsTimepoint: 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and 48 hrs after induction;Amount of analgesic required in 48 hours post operatively via Elastomeric Patient Controlled Analgesia (PCA) pumpTimepoint: 48 hours;Haemodynamic variables from baseline at different time intervals in both groupsTimepoint: 30 minutes, 1 hour, 2 hours, 3 hours post induction;Associated side effects like Nausea, Vomiting, tinnitus, dysgeusia, facial nerve injury, sensorineural hearing loss.Timepoint: 48 hours duration	—

Measure

Time frame

Difference in Visual Analog Score(VAS) of both groups at different time intervalsTimepoint: 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and 48 hrs after induction;Amount of analgesic required in 48 hours post operatively via Elastomeric Patient Controlled Analgesia (PCA) pumpTimepoint: 48 hours;Haemodynamic variables from baseline at different time intervals in both groupsTimepoint: 30 minutes, 1 hour, 2 hours, 3 hours post induction;Associated side effects like Nausea, Vomiting, tinnitus, dysgeusia, facial nerve injury, sensorineural hearing loss.Timepoint: 48 hours duration

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Countries

India

Contacts

Public ContactAnil Gupta

National Institute of Medical Sciences, Jaipur

ag27111855@gmail.com9829013538

Outcome results

None listed

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