A clinical trial to study the incidence and intensity of injection pain of two different formulations of drug propofol in patients requirin general anaesthesia
- Conditions
- ASA 1 and ASA 2
- Registration Number
- CTRI/2018/04/013125
- Lead Sponsor
- SDM College of Medical Sciences and Hospital
- Brief Summary
This study is a randomized, prospective, double blind trial performed to assess the incidence and intensity of propofol injection pain between two formulations.
Two hundred ASA physical status I & II patients, posted for various elective surgeries under general anaesthesia were studied.The patients were divided into two groups of hundred each.Group L received 3 cc of LCT propofol and Group M received 3ccof LCT/MCT propofol . Patients were observed and questioned after 30sec of injection and pain was scored on a 4 point scale. Pain recall was done on the same 4 point scale 30 mins postoperatively.
Both the incidence and intensity of pain was greater in group L compared with group M (p=0.0002). The mean pain score was also higher in group L (2.71) when compared with group M (1.08).
Propofol MCT/LCT reduces both intensity and incidence of pain on injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- 1.The subjects who are aged between 18 to 60 years belonging to ASA Physical status 1 and 2.
- Those willing to participate.
- 1.Patients with ischaemic heart diseases, neurological or psychiatric problems, renal or hepatic insufficiency, suspected or known airway difficulty.
- Pregnant or lactating women.
- Those who were taking any analgesics before surgery.
- Those with known hypersensitivity to propofol or to any of the constituents of emulsion.
- Those who refuse to give consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pain on propofol induction and pain recall postoperatively. Following 3cc of propofol induction pain will be assessed after 30 secs. Full dose of propofol will be given after assessing pain. | Pain recall postoperatively | 30 mins after the patient is shifted to post operative ward Verbal rating scale for injection pain and recall pain used. Following 3cc of propofol induction pain will be assessed after 30 secs. Full dose of propofol will be given after assessing pain. | Pain recall postoperatively | 30 mins after the patient is shifted to post operative ward
- Secondary Outcome Measures
Name Time Method changes in Pulse rate, Non invasive Blood pressure and Saturation pre induction, induction, postoperatively
Trial Locations
- Locations (1)
SDM College of medical sciences and hospital
🇮🇳Dharwad, KARNATAKA, India
SDM College of medical sciences and hospital🇮🇳Dharwad, KARNATAKA, IndiaSupreeth R ShettyPrincipal investigator9945619565supreethrshetty@gmail.com