Pain, AcuteNCT04762121
Observational Peripheral IV Insertion Study
An observational study of Pain, Acute and Satisfaction, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Satisfaction
- What is being tested?
- Peripheral IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2012to 23 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients requiring intravenous catheter insertion for their operation/procedure.
Who may be able to join
- Adults ages 18 to 99
- Patients requiring intravenous catheter insertion for their operation/procedure.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
About this study
Official title: Preliminary Prospective Observational Study on Peripheral Intravenous Catheter Insertion
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.
Read the 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.
- Conditions
- Pain, Acute, Satisfaction
- Being tested
- Peripheral IV
- Medical subject headings
- Acute Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral IVProcedure or surgery
Insertion of peripheral intravenous catheter
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring intravenous catheter insertion | Adults (>18 years old) who require intravenous catheter insertion for their operation/procedure Receives: Procedure: Peripheral IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with IV Cannulation based on the Visual Analog Scale
How much pain do adult patients experience with peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Secondary outcomes (6)
Satisfaction with IV cannulation based on the Numerical Rating Scale
How much satisfaction do adult patients experience with peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device? The Numerical Rating Scale is used for linear measurement of satisfaction, where the minimum number is 1 (very dissatisfied) and the maximum number is 5 (very satisfied).
Measured: 5-20 minutes
Pain related to IV location based on the Visual Analog Scale
Does location of the peripheral intravenous catheter placement affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Pain related to IV size based on the Visual Analog Scale
Does size of the peripheral intravenous catheter affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Pain from IV insertion related to stage of the training of the healthcare provider based on the Visual Analog Scale
Does the stage of the training of the healthcare provider affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Pain from IV insertion based on the Visual Analog Scale related to history of patient having anxiety
Does the history of patient having anxiety affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Pain from IV insertion based on the Visual Analog Scale related to history of patient having depression
Does the history of patient having depression affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Measured: 5-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Feb 2012
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Why it stopped: Investigators left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762121
- Sponsor's protocol ID
- EX070
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Prospective Observational Study on Peripheral Intravenous Catheter Insertion
- ClinicalTrials.gov ID
- NCT04762121
- Acronym / sponsor ID
- EX070
- Conditions
- Pain, Acute, Satisfaction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigators left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 12 Feb 2012 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring intravenous catheter insertion | – | Procedure: Peripheral IVAdults (>18 years old) who require intravenous catheter insertion for their operation/procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring intravenous catheter insertion for their operation/procedure.
Key inclusion criteria (2 listed)
- Adults ages 18 to 99
- Patients requiring intravenous catheter insertion for their operation/procedure.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral IVInsertion of peripheral intravenous catheter | Procedure or surgery | Patients requiring intravenous catheter insertion |
Primary outcome
Pain with IV Cannulation based on the Visual Analog Scale
Time frame: 5-20 minutes
How much pain do adult patients experience with peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
6 secondary outcomes
Satisfaction with IV cannulation based on the Numerical Rating Scale
Time frame: 5-20 minutes
Pain related to IV location based on the Visual Analog Scale
Time frame: 5-20 minutes
Pain related to IV size based on the Visual Analog Scale
Time frame: 5-20 minutes
Pain from IV insertion related to stage of the training of the healthcare provider based on the Visual Analog Scale
Time frame: 5-20 minutes
Pain from IV insertion based on the Visual Analog Scale related to history of patient having anxiety
Time frame: 5-20 minutes
Pain from IV insertion based on the Visual Analog Scale related to history of patient having depression
Time frame: 5-20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute and Satisfaction, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with IV Cannulation based on the Visual Analog Scale (time frame: 5-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.