A Comparative study to decrease incidence of pain on injection of propofol using newer preparations of propofol emulsion.

Completed

Conditions: children aged 6-12years under ASA 1 and 2 undergoing any elective surgical procedure under general anaesthesia

Registration Number: CTRI/2018/01/011562

Lead Sponsor: Vijayanagar Institute of Medical Sciences Ballari

Brief Summary: Propofol is the most frequently used IV anaesthetic today. Propofol, when used for induction of anaesthesia in brief procedures, results in a significantly quicker recovery and an earlier return of psychomotor function compared with other induction agents. Induction ofanaesthesia is associated with several side effects with pain during intravenous injection being major among them. In view of the above consideration, this clinical study was performed to assess the comparative effects of 0.5% dilution of propofol MCT/LCT with 0.5% dilution of propofol LCT on injection pain.

A hundred ASA physical status I & II patients ,aged 6-12 years, both male and female posted for various elective surgeries under general anaesthesia were studied.

The patients were divided into two groups of fifty each:

**Group** **LCT &Group MCT/ LCT** (N = 50 ), according to the computer generated list.

**Group** **LCT** received 0.5% dilution of propofol (LCT) at 2mg/kg

**Group** **MCT/ LCT** received 0.5% dilution of propofol (MCT LCT) at 2mg/kg

Pain on propofol injection was assessed using Mc Crirrick and Hunter scale of evaluation of propofol injection pain.The patients in both groups were comparable with respect to demographic and hemodynamic parameters.Our study showed that 66% of group MCT/LCT and 12% of group LCT had no pain at all. While 8% in group MCT/LCT and 4% in group LCT had mild pain. The patients who experienced moderate pain were 18% in group MCT/LCT and 54% in group LCT,while only 8% had severe pain in group MCT/LCT compared to 30% in group LCT The difference in pain on injection was significantly less in group 0.5% MCT/LCT compared to group 0.5% LCT with P value of 0.0000 being highly significant. Hence we can conclude that using 0.5% dilution of propofol MCT/LCT has significantly reduced the incidence,intensity and severity of pain on propofol injection.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

ASA 1 and ASA 2 patients.

Exclusion Criteria

ASA 3 and 4 patients co existing systemic disease contra indication to propofol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of 0.5% dilution of propofol MCT/LCT with propofol LCT for injection pain during induction of general anaesthesia (GA) in paediatric patients.	15 seconds, 30 seconds and 1 minute intervals.

Secondary Outcome Measures

Name	Time	Method
To compare the effect of 0.5 % dilution of propofol MCT/LCT with propofol LCT on haemodynamic changes during induction of GA in both the groups.	15 seconds, 30 seconds and further at 1 minute intervals upto 5 minutes after induction

Trial Locations

Locations (1): vijayanagar institute of medical sciences, Ballari
🇮🇳
Bellary, KARNATAKA, India
vijayanagar institute of medical sciences, Ballari
🇮🇳Bellary, KARNATAKA, India
DrSameera
Principal investigator
9742326961
sameerapatel7464@gmail.com