Propofol Injection Pain
Conditions
Keywords
propofol injection pain, propofol pain, passive arm elevation, lidocaine pretreatment,
Brief summary
The purpose of this research is to determine whether a simple technique, temporarily raising the arm during the injection of propofol (a commonly used medication for anesthesia), can reduce the pain that some people experience when the medication is given through an IV. The study will compare this technique with the current standard approach of using lidocaine (a numbing medication), as well as a combination of both methods, to determine which approach is most effective at reducing injection pain.
Interventions
PROCEDUREPassive arm elevation
The cannulated arm is passively elevated approximately 60 to 90 degrees at the start of propofol injection and maintained briefly during and immediately after the injection before being returned to heart level.
DRUGNormal saline
Normal saline 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection.
DRUGLidocaine
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.
DRUGPropofol
Standard LCT propofol administered as a standardized subanesthetic test dose, calculated as one-quarter of a 2.5 mg/kg induction dose using total body weight up to BMI 30 or ideal body weight above BMI 30, with a maximum study dose of 50 mg.
PROCEDURESham arm elevation
The contralateral non-IV arm is elevated while the cannulated arm remains neutral.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA I-III * 18G or 20G dorsal hand working IV in place (drip by gravity) * Planned IV propofol infusion with natural airway * Able to provide consent * Able to report pain * English-speaking
Exclusion criteria
* Allergy to propofol/lidocaine * Significant cognitive impairment/acute psychosis * Any sedative medications given prior to the study * Pregnancy * Severe upper-extremity mobility limitation that prevents safe arm elevation * Emergency medical condition; (e.g. GI bleeding, sepsis, acute heart or respiratory failure) * Chronic pain syndrome with chronic opioid use * Any acute pain condition that may be distracting to the patient * Any report of pain on gravity drip, injection of saline or spontaneous pain when testing the iv in preop prior to bringing the patient to the OR * Pathology or prior surgery that is deemed to interfere with normal venous drainage of the arm (arterio-venous fistula, history of port or dialysis line, , history of heart failure) * History of past or current cardiac arrhythmias, cardiac valvular abnormalities, /heart failure, stable angina that are expected to require concomitant administration of vasoactive or inotropic medications with induction * TIA or stroke within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Any Propofol Injection Pain | Within approximately 30 seconds from the start of propofol injection. | Proportion of participants reporting any propofol injection pain during or immediately after the standardized propofol test dose, defined as a verbal rating scale score of 1 or greater on a 4-point verbal rating scale where 0 indicates no pain, 1 mild pain, 2 moderate pain, and 3 severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity Score | Within approximately 30 seconds from the start of propofol injection. | Pain severity measured as the participant's highest pain score during or immediately after the standardized propofol test dose using a 4-point verbal rating scale, where 0 indicates no pain, 1 mild pain, 2 moderate pain, and 3 severe pain. |
| Incidence of Moderate-to-Severe Propofol Injection Pain | Within approximately 30 seconds from the start of propofol injection. | Proportion of participants with moderate-to-severe propofol injection pain, defined as a verbal rating scale score of 2 or 3 on the 4-point verbal rating scale. |
Countries
United States
Contacts
CONTACTMariel Anne Reyes
CONTACTAlly Sapin
PRINCIPAL_INVESTIGATORFerenc Rabai, MD
Mayo Clinic
Outcome results
None listed