PainNCT05957718
Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
A study testing TKTX cream in people with Pain and Fear of Pain, run by Uppsala University at 1 site in Iraq.
Trial summary
Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain, Fear of Pain, Venipuncture Site Numbness
- What is being tested?
- TKTX cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteIraq
- Study dates
- 2 Aug 2022to 4 Sep 2023
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School-age Children and
- Required needle procedures
Who cannot join
- Neurodevelopmental problems
- Chronic disease
- Taken Analgesic
Trial locations and contacts
1 site in 1 country.
About this study
Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Therefore, implementing effective pain management strategies during venipuncture is crucial to ensure patient comfort and improve the overall healthcare experience. This comprehensive overview aims to highlight the significance of pain management during venipuncture procedures.
This study will investigate the effects of a pharmacological approach on the pain that children experience during venipuncture in a randomized trial.
TKTX topical anesthetic cream is a new commercially available product. In this study, the cream will be used for a shorter period of time than other creams used in previous studies, and it will also be free of side effects as they have been in previous studies with other creams.
Read the detailed description
Venipuncture is a common medical procedure involving the insertion of a needle into a vein, often causing discomfort and pain. To alleviate this pain, pharmacological approaches have been widely explored. The efficacy of these approaches in managing venipuncture-related pain is of utmost importance for both healthcare professionals and patients. Various pharmacological options have been studied, including topical anesthetics such as lidocaine creams or patches, local anesthetic injections like buffered lidocaine or ethyl chloride spray, and systemic analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.
You may experience some pain, often a brief sting, when the needle is inserted into and removed from your arm.
Non-pharmacological pain intervention is a prophylactic and complementary approach to reduce pain.
Ensuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance.
Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA (r), amethocaine and lidocaine.
Evaluating the effectiveness of these interventions requires considering factors like onset and duration of action, adequate pain relief achieved, patient satisfaction levels, and potential adverse effects.
- Conditions
- Pain, Fear of Pain, Venipuncture Site Numbness
- Being tested
- TKTX cream
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKTX creamDrug
Also called Placebo (Vasaline)
TKTX cream was used in several studies on Tatto and laser
| Study group | Role | What they receive |
|---|---|---|
| TKTX Group | Experimental | In this group, We will use TKTX cream as a local anesthesia Receives: Drug: TKTX cream |
| Control Group | Placebo comparator | In this group, we will use a Vasalin as Placebo Receives: Drug: TKTX cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Scale Pain
Was used to measure Children's pain scale
Measured: 2-3 min. after procedure
Secondary outcomes (1)
Child Fear Scale
Was used to measure Children's fear scale
Measured: 2-3 min. after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start2 Aug 2022
- Primary completion3 Feb 2023
- Study completion4 Sep 2023
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.
- More trials run by Uppsala UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957718
- Sponsor's protocol ID
- Sherzad
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05957718
- Acronym / sponsor ID
- Sherzad
- Conditions
- Pain, Fear of Pain, Venipuncture Site Numbness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 24 Jul 2023 (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.
Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Therefore, implementing effective pain management strategies during venipuncture is crucial to ensure patient comfort and improve the overall healthcare experience. This comprehensive overview aims to highlight the significance of pain management during venipuncture procedures.
This study will investigate the effects of a pharmacological approach on the pain that children experience during venipuncture in a randomized trial.
TKTX topical anesthetic cream is a new commercially available product. In this study, the cream will be used for a shorter period of time than other creams used in previous studies, and it will also be free of side effects as they have been in previous studies with other creams.
Detailed description
Venipuncture is a common medical procedure involving the insertion of a needle into a vein, often causing discomfort and pain. To alleviate this pain, pharmacological approaches have been widely explored. The efficacy of these approaches in managing venipuncture-related pain is of utmost importance for both healthcare professionals and patients. Various pharmacological options have been studied, including topical anesthetics such as lidocaine creams or patches, local anesthetic injections like buffered lidocaine or ethyl chloride spray, and systemic analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.
You may experience some pain, often a brief sting, when the needle is inserted into and removed from your arm.
Non-pharmacological pain intervention is a prophylactic and complementary approach to reduce pain.
Ensuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance.
Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA (r), amethocaine and lidocaine.
Evaluating the effectiveness of these interventions requires considering factors like onset and duration of action, adequate pain relief achieved, patient satisfaction levels, and potential adverse effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKTX Group | Experimental | Drug: TKTX creamIn this group, We will use TKTX cream as a local anesthesia |
| Control Group | Placebo comparator | Drug: TKTX creamIn this group, we will use a Vasalin as Placebo |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School-age Children and
- Required needle procedures
Key exclusion criteria (3 listed)
- Neurodevelopmental problems
- Chronic disease
- Taken Analgesic
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 |
|---|---|---|
| TKTX creamAlso: Placebo (Vasaline)TKTX cream was used in several studies on Tatto and laser | Drug | Control Group, TKTX Group |
Primary outcome
Wong-Baker Scale Pain
Time frame: 2-3 min. after procedure
Was used to measure Children's pain scale
1 secondary outcome
Child Fear Scale
Time frame: 2-3 min. after procedure
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 20 Feb 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?
A study testing TKTX cream in people with Pain and Fear of Pain, run by Uppsala University at 1 site in Iraq.
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 3 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 20 Feb 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 Iraq. 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. 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.
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?
Wong-Baker Scale Pain (time frame: 2-3 min. after procedure). 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 20 Feb 2024.