Injection Site Irritation Clinical Trial
— ValsalvaOfficial title:
Comparison of Valsalva Manoeuvre and Intravenous Dexmedetomidine on Attenuating Pain During Propofol Injection in Upper Gastrointestinal Endoscopy: A Prospective Randomized Controlled Study
Verified date | October 2022 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
No previous study has cited the use of the Valsalva manoeuvre for the reduction of pain on propofol injection in comparison with dexmedetomidine injection. Therefore, investigators plan a study to evaluate the analgesic efficacy of the Valsalva manoeuvre in alleviating pain during propofol injection as compared to dexmedetomidine injection.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 10, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Adult patients aged 30-60 years old. 2. American Society of Anesthesiologist physical status(ASA) Grade I and II. 3. Upper gastrointestinal Endoscopies. Exclusion Criteria: 1. Patients with mental illness, restlessness. 2. Cardio-respiratory disease. 3. Chronic pain disorder. 4. Use of preoperative analgesic medication. 5. History of propofol allergy. 6. History of drug abuse. 7. Inability to perform the Valsalva manoeuvre. - |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Sharurah Armed Forces Hospital | Sharurah | Najran |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Assessment | using a ruler as the visual analogue scale(VAS), The VAS score ranged from 0-10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will be instructed to mark a point on the VAS ruler that represented the intensity of pain. The pain score was determined by measuring the distance in mm between 0 (no pain) and the mark will be indicated by the patient on the ruler. | 20 seconds after propofol injection. | |
Secondary | Withdrawal response score | withdrawal response will be assessed using standard questions including comfort during injection, verbal response, and behavioural signs (facial grimacing, arm withdrawal, or tears). the withdrawal response scoring will be graded on a 4-point scale: 0 = no pain, 1 = mild pain (pain reported only in response to questioning without any behavioural signs), 2 = moderate pain (pain reported in response to questioning and accompanied by behavioural signs or pain reported spontaneously without questioning), and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears). | 20 seconds after propofol injection | |
Secondary | Heart Rate(HR) beat / minute | the heart rate (HR) will be recorded before the Valsalva manoeuvre, at 1 minute, at 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on | 10 minutes | |
Secondary | Propofol injection site reaction | the propofol injection site will be checked for signs of inflammation including oedema, pain, wheal, and flare | 24 hour | |
Secondary | Non-invasive blood pressure(NIBP) mmHg | Non-invasive blood pressure(NIBP) will be recorded before the Valsalva manoeuvre, at 1 minute, 2 minutes after the manoeuvre, following propofol injection, and 5 minutes later on. | 10 minutes. |
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