AnalgesiaNCT03749915
Ametop Compared to Ametop With Pain Ease Spray
A study testing Pain Ease Cold Spray and Ametop in people with Analgesia and Topical Anesthetic, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Analgesia, Topical Anesthetic
- What is being tested?
- Pain Ease Cold Spray and Ametop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2018to 31 Dec 2019
- Phase
- Interventional
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I \& II
- Elective day case procedure requiring an IV
Who cannot join
- Planned IV insertion after inhalation induction
- Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10
- Ametop Gel™ application < 30 minutes before estimated IV start at time of screening
- Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives
- Patients receiving sedative pre-medication
- Severe Needle phobia
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, V5Z 4V4
Andrew Poznikoff, BSc, 604-875-2000 ext. 1989, andrew.poznikoff@cw.bc.ca
Stephan Malherbe, MBBS, FRCA, 604-875-2711, smalherbe@cw.bc.ca
About this study
Official title: A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.
Read the detailed description
Purpose:
The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.
Hypothesis:
The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.
Objectives:
Primary Objective
- To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives
- To document the side effects of Pain Ease® spray and Ametop Gel™
- To document the number of attempts for a successful IV insertion
Research Design:
The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and without Pain Ease® spray as an adjunct.
Statistical Analysis:
An interim analysis will be performed at the study's halfway point after recruitment of 120 participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be considered a pain-free IV start, while a score of 4-10 will be considered a painful IV cannula insertion. Fischer's Exact test will be used to determine statistical significance; a critical alpha of 0.05 will be considered for significance.
- Conditions
- Analgesia, Topical Anesthetic
- Being tested
- Pain Ease Cold Spray, Ametop
- Keywords
- Pain Ease, Ametop Gel
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Ease Cold SprayDevice
Pain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic.
AmetopDrug
Also called Ametop Gel
Tetracaine Hydrochloride Gel 4%
| Study group | Role | What they receive |
|---|---|---|
| Comparator: Ametop only | Active comparator | Ametop Gel applied as sole topical anesthetic. Receives: Drug: Ametop |
| Intervention: Pain Ease Cold Spray | Experimental | Pain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel. Receives: Device: Pain Ease Cold Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free IV insertion
The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised.
Measured: intraoperative
Secondary outcomes (2)
Insertion attempts
Total number of insertion attempts required for successful placement of IV cannula
Measured: intraoperative
FPS-R pain score
Mean Faces Pain Scale - Revised pain score by group. 0-10 pain score of 0 being no pain and 10 being most pain ever experienced.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start20 Nov 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Malherbe, University of British Columbia
- Investigators
- Stephan Malherbe, FRCA, Principal investigator, BC Children's Hospital, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749915
- Sponsor's protocol ID
- H18-02364
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Observational Study of the Effectiveness of a Pain Ease Local Anesthetic Spray, Combined With Ametop Gel, to Reduce the Discomfort of Intravenous Insertion
- ClinicalTrials.gov ID
- NCT03749915
- Acronym / sponsor ID
- H18-02364
- Conditions
- Analgesia, Topical Anesthetic
- Keywords
- Pain Ease, Ametop Gel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Nov 2018 (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.
The investigators propose to examine if Pain Ease spray, used as an adjunct to the topical anesthetic Ametop Gel, can improve the percentage of pain-free IV starts.
Detailed description
Purpose:
The aim of this study is to assess the effectiveness of Pain Ease® spray, used as an adjunct to Ametop Gel™.
Hypothesis:
The investigators hypothesize that using Pain Ease® spray as an adjunct to the standard use of Ametop Gel™ will increase the number of pain free venipunctures from 30% to 50% or more.
Objectives:
Primary Objective
- To determine if using Pain Ease® spray as an adjunct to Ametop Gel™ will increase the number of pain free venipunctures Secondary Objectives
- To document the side effects of Pain Ease® spray and Ametop Gel™
- To document the number of attempts for a successful IV insertion
Research Design:
The investigators propose a patient-blinded randomized control trial of Ametop Gel™ with and without Pain Ease® spray as an adjunct.
Statistical Analysis:
An interim analysis will be performed at the study's halfway point after recruitment of 120 participants. A score on the Faces Pain Scale - Revised (FPS-R) of either 0 or 2 will be considered a pain-free IV start, while a score of 4-10 will be considered a painful IV cannula insertion. Fischer's Exact test will be used to determine statistical significance; a critical alpha of 0.05 will be considered for significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator: Ametop only | Active comparator | Drug: AmetopAmetop Gel applied as sole topical anesthetic. |
| Intervention: Pain Ease Cold Spray | Experimental | Device: Pain Ease Cold SprayPain Ease Cold spray applied immediately before IV insertion, as an adjunct to Ametop Gel. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I \& II
- Elective day case procedure requiring an IV
Key exclusion criteria (6 listed)
- Planned IV insertion after inhalation induction
- Developmental delay or inability to interpret the Revised Faces Pain Scale (FPS-R)10
- Ametop Gel™ application < 30 minutes before estimated IV start at time of screening
- Allergies to any of the components in Ametop Gel™, Pain Ease® spray, or adhesives
- Patients receiving sedative pre-medication
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 |
|---|---|---|
| Pain Ease Cold SprayPain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic. | Device | Intervention: Pain Ease Cold Spray |
| AmetopAlso: Ametop GelTetracaine Hydrochloride Gel 4% | Drug | Comparator: Ametop only |
Primary outcome
Pain-free IV insertion
Time frame: intraoperative
The number of pain free IV insertions as measured by participant indicating 0 or 2 on the Faces Pain Scale - Revised.
2 secondary outcomes
Insertion attempts
Time frame: intraoperative
FPS-R pain score
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Stephan Malherbe, FRCA principal investigator
BC Children's Hospital, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Ease Cold Spray and Ametop in people with Analgesia and Topical Anesthetic, run by University of British Columbia at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Nov 2018. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Poznikoff, BSc (604-875-2000 ext. 1989, andrew.poznikoff@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-free IV insertion (time frame: intraoperative). 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 21 Nov 2018.