PainPhase 4XylocaineNCT02562144
A Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
A Phase 4 study testing Xylocaine spray in people with Pain, run by Isala.
Trial summary
The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Xylocaine spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2016to 7 Apr 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (aged 18 or older)
- Signing of the informed consent paper
Who cannot join
- Allergy for xylocaine
- Pregnancy or breast-feeding
- Peripheral neuropathy
- Analgesics in the last 24 hours
- Skin conditions (eczema, psoriasis, infection, or abrasions)
- Difficulties in verbal communication
- No intravenous access in both elbows possible (eg status after axillary dissection )
About this study
Official title: A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
Read the detailed description
The enrolled subjects will get an intravenous cannulation in both elbows. The influence of the left or right-handedness is reduced by randomizing the arms of the subjects in the placebo group or xylocaine group. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
- Conditions
- Pain
- Being tested
- Xylocaine spray, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine sprayDrug
Also called Bananenspray, Lidocaine spray
Cutaneous xylocaine spray before intravenous cannulation.
PlaceboDrug
Also called NaCl
Cutaneous placebo before intravenous cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine spray | Experimental | Not described Receives: Drug: Xylocaine spray |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score of the tested subjects during intravenous cannulation
Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)
Measured: A few seconds after intravenous cannulation
Secondary outcomes (3)
Complications or adverse reactions of xylocaine spray or placebo spray
Measured: 5 minutes after xylocaine spray or placebo and 15 minutes after cannulation
Influence of xylocaine spray in successfully placing an IV cannulation
Is the cannulation easy or difficult to access on a scale, 0 to 10 (0 = easy, 10 = very difficult, almost impossible).
Measured: Before intravenous cannulation
The degree of difficulty in successfully placing an IV cannulation
Indicate in a scale from 10 (0 = easy, 10 = very difficult, almost impossible) or the cannulation was easy or difficult to access
Measured: A few seconds after intravenous cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start5 Apr 2016
- Primary completion6 Apr 2016
- Study completion7 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Datema, Isala
- Investigators
- Joris Datema, Drs, Principal investigator, Isala Zwolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562144
- Sponsor's protocol ID
- Isala
- Acronym
- Xylocaine
- Status last verified
- May 2017
- First submitted
- 17 Sep 2015
- Last updated
- 30 May 2017
- 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
- ClinicalTrials.gov ID
- NCT02562144
- Acronym / sponsor ID
- Xylocaine / Isala
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 6 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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.
The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
Detailed description
The enrolled subjects will get an intravenous cannulation in both elbows. The influence of the left or right-handedness is reduced by randomizing the arms of the subjects in the placebo group or xylocaine group. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine spray | Experimental | Drug: Xylocaine spray |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (aged 18 or older)
- Signing of the informed consent paper
Key exclusion criteria (7 listed)
- Allergy for xylocaine
- Pregnancy or breast-feeding
- Peripheral neuropathy
- Analgesics in the last 24 hours
- Skin conditions (eczema, psoriasis, infection, or abrasions)
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 |
|---|---|---|
| Xylocaine sprayAlso: Bananenspray, Lidocaine sprayCutaneous xylocaine spray before intravenous cannulation. | Drug | Xylocaine spray |
| PlaceboAlso: NaClCutaneous placebo before intravenous cannulation. | Drug | Placebo |
Primary outcome
The pain score of the tested subjects during intravenous cannulation
Time frame: A few seconds after intravenous cannulation
Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)
3 secondary outcomes
Complications or adverse reactions of xylocaine spray or placebo spray
Time frame: 5 minutes after xylocaine spray or placebo and 15 minutes after cannulation
Influence of xylocaine spray in successfully placing an IV cannulation
Time frame: Before intravenous cannulation
The degree of difficulty in successfully placing an IV cannulation
Time frame: A few seconds after intravenous cannulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- 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.
Joris Datema, Drs principal investigator
Isala Zwolle
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xylocaine spray in people with Pain, run by Isala.
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 7 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The pain score of the tested subjects during intravenous cannulation (time frame: A few seconds after intravenous cannulation). 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 30 May 2017.