Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002263637 Date of Approval: 04/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Premedication With Intravenous Lornoxicam on Propofol Injection Pain At Induction of General Anaesthesia in Adults.
Official scientific title The Effect of Premedication With Intravenous Lornoxicam on Propofol Injection Pain at Induction of General Anaesthesia in Adults; A Randomised Placebo-Controlled Trial.
Brief summary describing the background and objectives of the trial Background: Propofol is widely used for the induction and maintenance of general anaesthesia and offers many attractive pharmacological qualities that make it suitable for these indications. However, pain on injection is one of its major drawbacks and can be very distressing to patients. Although many interventions have been studied and some found to be effective in reducing the pain associated with propofol injection, no single intervention has succeeded in eliminating this problem completely. Additionally, no study has yet looked at the effect of lornoxicam on propofol injection pain either as a sole intervention or in combination with any other method. Lornoxicam is a relatively new NSAID with a demonstrably stronger analgesic effect and better safety and tolerability profile than most drugs in its class. It is frequently used in anaesthesia as part of a multimodal approach to pain management. Primary Objective: To determine whether premedication with intravenous lornoxicam in addition to a standard lignocaine-propofol admixture has any effect on the intensity of propofol injection pain at induction of general anaesthesia. Study Design: A single centre, randomized, placebo-controlled trial. Methods: Adult patients of ASA physical status 1 and 2 will be recruited from the anaesthesia clinic, day surgery unit and the wards and randomized into two groups after informed consent is obtained. The intervention group will receive lornoxicam 30 minutes prior to induction of anaesthesia while the control group will receive saline. Following a standardized anaesthetic protocol, both groups will then receive a propofol-lignocaine admixture at induction of general anaesthesia and the pain scores during propofol injection recorded using the adult non-verbal pain score. Both the patient and the anaesthesiologist recording the pain scores will be blinded as to what intervention the patient received.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Propofol Injection Pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2017
Actual trial start date
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 156
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program. Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lornoxicam 8mg STAT STAT Premedication with Lornoxicam prior to propofol injection 78
Control Group Saline 2mls STAT Inactive placebo 78 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients aged 18 to 65 years ASA physical status 1 and 2 Systemic Arterial Hypertension. Pregnancy. History of or active phlebitis/thrombophlebitis. Allergy or hypersensitivity (asthma, rhinitis, angioedema or urticaria) to lornoxicam and any of its excipients. Presence of any contraindication to NSAID use and particularly: Renal disease/renal impairment Hypersensitivity to any other NSAIDs Documented thrombocytopenia Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy Active or history of recurrent peptic ulcer/haemorrhage Severe hepatic impairment Severe heart failure. Patients already on other NSAID therapy. Language barriers in eexplaining study plan and obtaining consent. Difficult venous access (more than 2 attempts and/or <G20 cannula) Patients presenting for emergency surgery. Patients in pain. ASA physical status 3 and 4. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 22/05/2017 The Aga Khan University Hospital Ethics and Research Committee.
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 30270-00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intensity of propofol injection pain. At induction of general anaesthesia.
Secondary Outcome Incidence of propofol injection pain At end of study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aga Khan University Hospital, Nairobi. 3rd Parklands Avenue Nairobi 30270-00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Residency Training Research Grant 3rd Parklands Avenue Nairobi 30270-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Post Graduate Medical Education Programme 3rd Parklands Avenue Nairobi 30270-00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Prof. Vitalis Mung'ayi 3rd Parklands Avenue Nairobi 30270-00100 Kenya
Dr. Omari Dennis Onyancha 3rd Parklands Avenue Nairobi 30270-00100 Kenya
Dr. Ednah Kemunto Gisore 3rd Parklands Avenue Nairobi 30270-00100 Kenya
Dr. Sikolia Wanyonyi 3rd Parklands Avenue Nairobi 30270-00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vitalis Mung'ayi mung'ayi.vitalis@aku.edu +254724904010 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Consultant Anaesthesiologist
Role Name Email Phone Street address
Public Enquiries Dennis Omari Onyancha dennis.onyancha@aku.edu +254725944911 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Anaesthesiology Resident
Role Name Email Phone Street address
Scientific Enquiries Vitalis Mung'ayi mung'ayi.vitalis@aku.edu +254724904010 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 30270-00100 Kenya Consultant Anaesthesiologist
REPORTING
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