Pain Due to Certain Specified Procedures Clinical Trial
Official title:
Vibration Anesthesia for Propofol- Rocuronium Injection Pain
NCT number | NCT04987866 |
Other study ID # | E1-21-1740 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | May 31, 2021 |
Verified date | April 2021 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite numerous strategies for preventing or alleviating pain associated with propofol and rocuronium injections, it remains common and distressing for patients. Vibration is an effective method of reducing pain during facial cosmetic injections and some venipuncture procedures. But it has not been previously studied in the context of propofol or rocuronium injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on the incidence and severity of propofol and rocuronium injection pain.
Status | Completed |
Enrollment | 52 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ASA I-II patients - Patients who are planned to undergo gynecology operations Exclusion Criteria: - Participants who were pregnant, - Patients who had a recent history of a severe allergic or hypersensitivity reaction to propofol or rocuronium |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | preventing or reducing propofol injection pain | Observer rated the pain responses according to a four-point scale. After the injection of propofol to, we also asked the patients whether they had any discomfort.The severity of propofol- injection was evaluated using the following four-point pain response scale developed by McCrirrick and Hunter: level 0: (no pain) no verbal/ facial/ motor reaction to the injection; level 1: (mild pain) a minor verbal/ facial/ motor reaction to the injection but no physical activity or wrist joint movements; and level 2: (moderate pain), pain when asked by the anesthesiologist, or complaint of pain during the injection accompanied by physical activity- facial grimacing or withdrawal of the arm (elbow-shoulder); and level 3: (sever pain), a response accompanied by a facial expression of pain, or a strong vocal response, tears, arm withdrawal, and full body reaction ( including other body movements) | patients were observed during and after the injection of propofol for 20 seconds by an observer | |
Primary | preventing or reducing rocuronium injection pain | The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS). The scale was 0: no movement, 1: movement only the wrist, 2: movement of only the arm (elbow-shoulder) and, 3: general response, movement more than one extremity. 2 minutes after induction, intubation was completed. | patients were observed during and after the injection of rocuronium for 20 seconds by an observer |
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