Injections, Intravenous Clinical Trial
Official title:
Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 20, 2017 |
Est. primary completion date | January 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection. - Cases must be schedule to have a duration less than 60 minutes. Exclusion Criteria: - Subjects are excluded if they cannot verbalize a rating of pain - Subjects are excluded if they require intravenous medications prior to the study period |
Country | Name | City | State |
---|---|---|---|
United States | North Carolina Baptist Hospital | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Expression of Pain | Patient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: None (0) Mild (1) Moderate (2) Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome). |
During injection at beginning of study; lasts 10 seconds one time only | |
Secondary | Subject's Recall of Injection Discomfort | Investigator asks patient if they recall discomfort during injection after the procedure. Patient's verbal rating and recall of pain during injection. We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: None (0) Mild (1) Moderate (2) Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome). |
This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only | |
Secondary | Investigators Rating of Patient Discomfort | Investigator rates patient's nonverbal display of discomfort. Investigator Assessments: Induction Discomfort Scale (during injection and within 5 seconds after injection) No change in patient behavior (0) Grimace (1) IV forearm withdrawal (2) Moaning (3) Verbal statement of discomfort ("it hurts", etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced. |
During injection at beginning of study period; lasts 10 seconds one time only |
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