Ketamine nebulisation in Post-operative sore throat

Completed

Conditions: post operative sore throat

Registration Number: CTRI/2017/12/011009

Lead Sponsor: Dr Madhava Reddy R

Brief Summary: **Background** : 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 post-operative sore throat. In literature there is no study evaluating dose-dependent effectiveness of ketamine nebulisation, neither has there been a study to assess patient acceptability with ketamine nebulisation. The prime objective of this study was to assess graded doses of ketamine nebulization in attenuation of post-operative sore throat and patient acceptability and satisfaction.

**Materials and Methods**: 90 patients between age group of 18 and 60 years of ASA physical status 1 and 2 of either sex undergoing surgeries in supine position under general anaesthesia lasting for more than one hour were randomly allocated into three groups. Group A received 0.5 mg/kg, group B received 1 mg/kg and group C received 1.5mg/kg body weight of nebulized preservative free ketamine for 15 minutes, 5 minutes before intubation. The patients were then assessed for acceptability to ketamine nebulization. At the end of the surgery post-operative sore throat was assessed at 0, 2, 4, 6, 8, 12 and 24 hours.

**Results**: Nebulized ketamine at a dose of 0.5 mg/kg was comparatively less effective than 1 mg/kg and 1.5 mg/kg and the difference was statistically significant. 1 mg/kg and 1.5 mg/kg of nebulized ketamine are better and equally effective in reducing the incidence and severity of post-operative sore throat. There was no statistical difference in the acceptability scores to the different doses of nebulised ketamine.

**Conclusion**: Nebulized ketamine is well accepted by all patients and effective in reducing the severity of post-operative sore throat without any untoward effects. However larger population estimation of serum ketamine levels is needed to find out a better dose of ketamine for nebulization to prevent the incidence and severity of post-operative sore throat.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

ASA physical status 1 and 2 2.
patients undergoing surgeries in supine position under general Anaesthesia 3.
surgeries lasting more than one hour.

Exclusion Criteria

Patients with Mallampati class greater than 2 2.
pre-operative sore throat, 3.
allergy to study drug, 4.
recent history of NSAID medication, 5.
smokers, asthmatics, patients with COPD, 6.head and neck surgeries, 7.those who require more than two attempts at intubation, 8.surgeries requiring nasogastric tube and throat pack insertion.
9.Patients in whom extubation caused coughing or bucking.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post operative sore throat at 4 hours	4 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1): Kempegowda Institute Of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
Kempegowda Institute Of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Madhava Reddy
Principal investigator
9379094790
madhavareddy.r@gmail.com