Ketamine gargle and nebulisation in post operative sore throat

Completed

• Conditions: middle ear surgeries

• Registration Number: CTRI/2018/01/011165
• Lead Sponsor: Dr Samrin Fiaz

Brief Summary

BACKGROUND AND OBJECTIVES Sore throat is a common and distressing post operative complication following endotracheal intubation that contributes to patient discomfort. Several pharmacological and non-pharmacological methods may be used to attenuate postoperative sore throat. Very few studies have been conducted to compare the effectiveness of ketamine gargle and nebulization in the attenuation of post operative sore throat. Moreover, no study has assessed for patient acceptability and satisfaction with the method of administration, volume and taste of the study drug.

METHODOLOGY Eighty patients belonging to ASA physical status 1 and 2, scheduled for ear surgeries under general anaesthesia were randomly allocated into two groups A and B. Group A received 50 mg ketamine gargle for 30 seconds and Group B received 50 mg ketamine nebulization for 15 minutes, 5 minutes before general anaesthesia. Patient acceptability and satisfaction with the study drug was assessed on a three point scale. Postoperatively sore throat was assessed at 0, 2, 4, 6, 8, 12 and 24 hours using four point scale(0-3).



RESULTS The overall incidence of post operative sore throat was found to be 45.9% and 36.8% in group A and B respectively, with no statistical difference between the two. None of the patients in either group experienced moderate and severe sore throat. 4 patients in Group A expressed dissatisfaction due to bitter taste and volume of the gargle and 1 patient in Group B due to the taste. There were no complications during the entire period of our study.



INTERPRETATION AND CONCLUSION Ketamine nebulisation is better accepted by patients and an effective alternative to ketamine gargle in attenuating post operative sore throat.



Key words: Ketamine, gargle, nebulization, post operative sore throat, tracheal intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Study Completion: 2017-04-29
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA physical status 1 and 2.
• Patients undergoing ear surgeries under general anaesthesia.
• Patients aged 18-60 years of either sex 4.
• Surgeries lasting more than one hour.

Exclusion Criteria

• Pre-operative sore throat 2.
• Mallampatti class >2 3.
• Allergy to the study drug 4.
• Recent history of NSAID medication 5.
• Asthmatics and patients with COPD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post operative sore throat	0,2,4,6,8,12,24 hours

Secondary Outcome Measures

Name	Time	Method
Patient acceptability and satisfaction score	immediately after drug administration

Trial Locations

Locations (1)

Major OT complex, A block, 4th floor,Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Major OT complex, A block, 4th floor,Kempegowda Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Samrin Fiaz

Principal investigator

9535215813

samrin.fiaz@gmail.com