Clinical trial NCT04762121: Observational Peripheral IV Insertion Study
Official title: Preliminary Prospective Observational Study on Peripheral Intravenous Catheter Insertion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain, Acute
Satisfaction
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring intravenous catheter insertion for their operation/procedure.

Brief summary: IV placement is a common and necessary for surgical procedures. Unfortunately, pain associated with needle catheterization experienced during peripheral IV placement is a source anxiety and discomfort in many patients. The intensity of pain and distress caused by procedures can vary from mild to moderate, but also may be severe in certain patients resulting in numerous physiological, psychological, and emotional consequences. As such, the investigators ultimately aim to evaluate the techniques that could make the placement of the IV more comfortable.

Detailed description: As a preliminary study, the investigators are interested in conducting a prospective observational study to collect baseline data to characterize and collect baseline data on pain associated with needle catheterization in the hospital.

Many factors including size of needle, experience of the individual placing IV, previous history of depression may vary the IV placement experience of a patient; however, only some of these factors may directly affect the magnitude of pain experienced by a patient. Currently, there is limited literature available on what factors affect the pain/satisfaction patients experience with IV insertion. Soysal et al. have previously reported that depressed patients reported higher severity of pain during IV catheter placement than non-depressed patients in a cross-sectional, observational study (n= 925). The authors have also demonstrated that age, sex, site of IV catheter insertion, use of antidepressant drugs, and whether the individual placing the IV catheter is a nurse or physician do not affect the magnitude of pain. Similarly, Van Loon et al have demonstrated that insertion of a smaller sized peripheral intravenous catheter did not result in lower pain sensation. However, Galvin et al. conducted a randomized clinical trial that demonstrated that the site of IV catheter insertion makes a difference in the pain patients feel during IV catheter insertion. Furthermore, no study exists that has investigated whether patients experience a different magnitude of pain when different levels of physician trainees place the IV catheter. Also, no study exists that compares whether peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device affect the pain/satisfaction that patients experience with IV catheter insertion.

Through the conduction of this study, the investigators hope to further evaluate which factors and techniques affect the experience patients have with peripheral IV cannulation; this knowledge could help the investigators figure out ways to make IV cannulation as comfortable as possible for patients in the future.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18 to 99
* Patients requiring intravenous catheter insertion for their operation/procedure.

Exclusion Criteria:

-

Primary outcomes:
measure: Pain with IV Cannulation based on the Visual Analog Scale
timeFrame: 5-20 minutes
Secondary outcomes:
measure: Satisfaction with IV cannulation based on the Numerical Rating Scale
timeFrame: 5-20 minutes
measure: Pain related to IV location based on the Visual Analog Scale
timeFrame: 5-20 minutes
measure: Pain related to IV size based on the Visual Analog Scale
timeFrame: 5-20 minutes
measure: Pain from IV insertion related to stage of the training of the healthcare provider based on the Visual Analog Scale
timeFrame: 5-20 minutes
measure: Pain from IV insertion based on the Visual Analog Scale related to history of patient having anxiety
timeFrame: 5-20 minutes
measure: Pain from IV insertion based on the Visual Analog Scale related to history of patient having depression
timeFrame: 5-20 minutes
Other outcomes:
Locations:
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
References: