Cannula Site PainPhase 4NCT04246255
Pain Relief During Intravenous Cannulation in Pediatric Patients
A Phase 4 study testing Xylocaine 10% Oral in people with Cannula Site Pain and Local Anesthesia, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Performing intravenous (IV) cannulation to pediatric patients might be much harder than adult ones according to their anxiety levels. However, managing adult patients during intravenous cannulation is also challenging if he or she had a noxious memory about the situation or has a low pain threshold. Read more about this study
- Who is it for?
- Ages 72 to 215 months
- Conditions the study is for
- Cannula Site Pain, Local Anesthesia
- What is being tested?
- Xylocaine 10% Oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2020to 24 Aug 2020
- 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 72 to 215 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject has to be treated with any drug submitted via intravenous cannula.
- The subject weighted more than 10 kg.
- The subject has a maximum ASA-2 score.
Who cannot join
- Allergic to amide group local anesthetics.
- The subject has a dermatological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Method for Pain Relief, Intravenous Cannulation in Pediatric Patients; A Randomized Prospective Clinical Trial.
Performing intravenous (IV) cannulation to pediatric patients might be much harder than adult ones according to their anxiety levels. However, managing adult patients during intravenous cannulation is also challenging if he or she had a noxious memory about the situation or has a low pain threshold. Therefore, it is essential to relieve the pain of an IV needle or an IV cannula insertion in the pediatric patient population. Lidocaine Hcl spray (Xylocaine 10% Oral ) will be utilized to the research group, and Serum Physiologic (Serum Fizyolojik %0,9 10 ml ampule, Biofarma İlaç San. ve Tic A.Ş., İstanbul, Turkey) will be utilized to the control group of the study. Both medications will be administrated by spraying the formula three times to an adhesive bandage and placing it to the skin that IV cannulation will be performed. After waiting for a minimum of 5 to a maximum of 15 minutes ( waiting time is closely associated with the patient's anxiety level), IV cannulation will be performed from the same area by an experienced pediatric nurse. The investigator hypothesizes that utilizing the spray form of the Lidocaine Hcl formula to the skin with an adhesive bandage before IV cannulation might lower the pain of the manipulation in pediatric patients, which might cause lower anxiety levels with stable vital signs.
Read the detailed description
The G-Power 3.0.10. Computed required sample size (alpha:0.05, effect size:0.3 and power 0.8) related to t-test of the difference between two dependent means(matched pairs) according to the 5% change of before and after heartbeat outcome parameters with Standard derivations of ( -/+12 to +/-15). The total sample size of ninety participants is evaluated to be enough for the study. However, fifty participants are planned to be enrolled in each group (a total of 100 participants) to compensate for possible losses in this prospective, randomized clinical study. Six parameters will be evaluated, and three scales will be performed in each group. The six parameters are Heart Rate-1, Spo2-1, Body Temperature-1, Heart Rate-2, Spo2-2, Body Temperature-2. The three scales are 11 point Verbal Numeric Rating Scale-1, 11 point Verbal Numeric Rating Scale-2, and Visual Analog Scale. Those parameters will be measured non-invasively, without causing any pain.
The randomization is planned to be done with the sealed envelope modeling. One of the envelopes is planned to be chosen by each participant after the written consent form approval from the child and his/her parents. The envelopes have either a "C" letter or "L" letter inside representing C as {Group C: "The Control Group"}, representing L as {Group L: "The Lidocaine Group"} will be opened by the principal investigator. The bottle 1(Serum Physiologic inside) or bottle 2( Lidocaine inside) will be given to the ward nurse according to the letters in the envelope. The ward nurse will be blinded according to the ingredients in the bottles. The outcome parameters and the scales will be recorded by the nurse in the investigation. The nurse in the investigation will be blinded about the groups, the envelopes and the ingredients performed to the participants.
The study is planned to last in 4 months (16 weeks) time. However, in the middle of the study( 25 participants undertaken within each group), post-doc tests are planned to be done. If the power of the study according to the post-Hoc tests are more than 80%, the study will be stopped.
- Conditions
- Cannula Site Pain, Local Anesthesia
- Being tested
- Xylocaine 10% Oral, Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul
- Keywords
- Local Anesthesia, Cannula Site Pain, Lidocaine Hydrocloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine 10% OralDrug
Also called EJACERA%10 sprey, LINCAINE sprey %10, LOCANEST sprey %10, PRECOXIN %10 sprey
50 ml of lidocaine solution maintained from xylocaine 10% oral that transferred to a bottle with a spray pump which pumps 0,1ml for each pump will be used for the experiment.
3 pumps of lidocaine will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.
Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampulDrug
Also called Serum Fizyolojik Onfarma 10 Ml, 10 Ampul,, Serum Fizyolojik İzotonik %0,9 10 Ml, 100 Ampul, Serum Fizyolojik Biofarma % 0,9, 10 Ml 100 Ampul
50 ml of Serum physiologic in a bottle with a spray pump which pumps 0,1ml for each pump will be used for placebo.
3 pumps of placebo will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Serum Physiologic %0,9 ampules ; 0,3ml {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application Receives: Drug: Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul |
| Group L | Experimental | xylocaine %10 pump spray ; 30mg lidocaine {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application Receives: Drug: Xylocaine 10% Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate-1
Heart Beat per minute, data obtained from SpO2 pediatric probe, before IV cannula insertion
Measured: It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
SpO2-1
Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, before IV cannula insertion.
Measured: It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Body Temperature-1
Body temperature, data obtained from tympanic temperature, before IV cannula insertion
Measured: It is going to be measured in the second minute(2nd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Heart Rate-2
Heart Beat per minute, data obtained from SpO2 pediatric probe, after IV cannula insertion
Measured: It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
SpO2-2
Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, after IV cannula insertion.
Measured: It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Body Temperature-2
Body temperature, data obtained from tympanic temperature, after IV cannula insertion
Measured: It is going to be measured in the last 5 minutes period of the study(approximately in the 13th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Secondary outcomes (3)
11-point Verbal Numeric Rating Scale-1 (VNS-1)
The subject is going to be asked to rate the cannula insertion pain, which the subject had experienced before the study ( if they had no experience Outcome 7 would stay empty), verbally according to the intensity from 0-10 with 0 representing "no pain" and 10 representing "the most intense pain imaginable."
Measured: It is going to be measured in the third minute(3rd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Visual Analog Scales
The subject will be asked to rate the cannula insertion pain after insertion by placing a vertical mark on a 100 mm horizontal VAS. The left and right extremes of the VAS are labeled as; "least possible pain" and "worst possible pain" respectively. 100mm VAS is devided into 5 categorical descriptors: "much less pain," "a little less pain," "about the same pain," "a little more pain," or "much more pain."
Measured: It is going to be measured in the in the last 5 minutes period of the study(approximately in the 14th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
11-point Verbal Numeric Rating Scale-2 (VNS-2)
The subject is going to be asked to rate the cannula insertion pain after insertion verbally according to the intensity from 0-10 with 0 representing "no pain" and 10 representing "the most intense pain imaginable."
Measured: It is going to be measured in the in the last 5 minutes period of the study(approximately in the 15th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start3 Feb 2020
- Primary completion1 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannula Site 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ferda Kartufan, Yeditepe University
- Investigators
- Ferda F Kartufan, Asst.Prof., Principal investigator, Yeditepe University Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246255
- Sponsor's protocol ID
- KAEK 882
- Status last verified
- Aug 2020
- First submitted
- 27 Jan 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cozzi G, Borrometi F, Benini F, Neri E, Rusalen F, Celentano L, Zanon D, Schreiber S, Ronfani L, Barbi E. First-time success with needle procedures was higher with a warm lidocaine and tetracaine patch than an eutectic mixture of lidocaine and prilocaine cream. Acta Paediatr. 2017 May;106(5):773-778. doi: 10.1111/apa.13764. Epub 2017 Feb 21.
PubMed 28130888Kim WO, Song BM, Kil HK. Efficacy and safety of a lidocaine/tetracaine medicated patch or peel for dermatologic procedures: a meta-analysis. Korean J Anesthesiol. 2012 May;62(5):435-40. doi: 10.4097/kjae.2012.62.5.435. Epub 2012 May 24.
PubMed 22679540
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Pain Relief, Intravenous Cannulation in Pediatric Patients; A Randomized Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT04246255
- Acronym / sponsor ID
- KAEK 882
- Conditions
- Cannula Site Pain, Local Anesthesia
- Keywords
- Local Anesthesia, Cannula Site Pain, Lidocaine Hydrocloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 29 Jan 2020 (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.
Performing intravenous (IV) cannulation to pediatric patients might be much harder than adult ones according to their anxiety levels. However, managing adult patients during intravenous cannulation is also challenging if he or she had a noxious memory about the situation or has a low pain threshold. Therefore, it is essential to relieve the pain of an IV needle or an IV cannula insertion in the pediatric patient population. Lidocaine Hcl spray (Xylocaine 10% Oral ) will be utilized to the research group, and Serum Physiologic (Serum Fizyolojik %0,9 10 ml ampule, Biofarma İlaç San. ve Tic A.Ş., İstanbul, Turkey) will be utilized to the control group of the study. Both medications will be administrated by spraying the formula three times to an adhesive bandage and placing it to the skin that IV cannulation will be performed. After waiting for a minimum of 5 to a maximum of 15 minutes ( waiting time is closely associated with the patient's anxiety level), IV cannulation will be performed from the same area by an experienced pediatric nurse. The investigator hypothesizes that utilizing the spray form of the Lidocaine Hcl formula to the skin with an adhesive bandage before IV cannulation might lower the pain of the manipulation in pediatric patients, which might cause lower anxiety levels with stable vital signs.
Detailed description
The G-Power 3.0.10. Computed required sample size (alpha:0.05, effect size:0.3 and power 0.8) related to t-test of the difference between two dependent means(matched pairs) according to the 5% change of before and after heartbeat outcome parameters with Standard derivations of ( -/+12 to +/-15). The total sample size of ninety participants is evaluated to be enough for the study. However, fifty participants are planned to be enrolled in each group (a total of 100 participants) to compensate for possible losses in this prospective, randomized clinical study. Six parameters will be evaluated, and three scales will be performed in each group. The six parameters are Heart Rate-1, Spo2-1, Body Temperature-1, Heart Rate-2, Spo2-2, Body Temperature-2. The three scales are 11 point Verbal Numeric Rating Scale-1, 11 point Verbal Numeric Rating Scale-2, and Visual Analog Scale. Those parameters will be measured non-invasively, without causing any pain.
The randomization is planned to be done with the sealed envelope modeling. One of the envelopes is planned to be chosen by each participant after the written consent form approval from the child and his/her parents. The envelopes have either a "C" letter or "L" letter inside representing C as {Group C: "The Control Group"}, representing L as {Group L: "The Lidocaine Group"} will be opened by the principal investigator. The bottle 1(Serum Physiologic inside) or bottle 2( Lidocaine inside) will be given to the ward nurse according to the letters in the envelope. The ward nurse will be blinded according to the ingredients in the bottles. The outcome parameters and the scales will be recorded by the nurse in the investigation. The nurse in the investigation will be blinded about the groups, the envelopes and the ingredients performed to the participants.
The study is planned to last in 4 months (16 weeks) time. However, in the middle of the study( 25 participants undertaken within each group), post-doc tests are planned to be done. If the power of the study according to the post-Hoc tests are more than 80%, the study will be stopped.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampulSerum Physiologic %0,9 ampules ; 0,3ml {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application |
| Group L | Experimental | Drug: Xylocaine 10% Oralxylocaine %10 pump spray ; 30mg lidocaine {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application |
Who may qualify
- Ages
- 72 to 215 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The subject has to be treated with any drug submitted via intravenous cannula.
- The subject weighted more than 10 kg.
- The subject has a maximum ASA-2 score.
Key exclusion criteria (2 listed)
- Allergic to amide group local anesthetics.
- The subject has a dermatological disease.
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 10% OralAlso: EJACERA%10 sprey, LINCAINE sprey %10, LOCANEST sprey %10, PRECOXIN %10 sprey50 ml of lidocaine solution maintained from xylocaine 10% oral that transferred to a bottle with a spray pump which pumps 0,1ml for each pump will be used for the experiment. 3 pumps of lidocaine will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted. | Drug | Group L |
| Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampulAlso: Serum Fizyolojik Onfarma 10 Ml, 10 Ampul,, Serum Fizyolojik İzotonik %0,9 10 Ml, 100 Ampul, Serum Fizyolojik Biofarma % 0,9, 10 Ml 100 Ampul50 ml of Serum physiologic in a bottle with a spray pump which pumps 0,1ml for each pump will be used for placebo. 3 pumps of placebo will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted. | Drug | Group C |
Primary outcome
Heart Rate-1
Time frame: It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Heart Beat per minute, data obtained from SpO2 pediatric probe, before IV cannula insertion
SpO2-1
Time frame: It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, before IV cannula insertion.
Body Temperature-1
Time frame: It is going to be measured in the second minute(2nd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Body temperature, data obtained from tympanic temperature, before IV cannula insertion
Heart Rate-2
Time frame: It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Heart Beat per minute, data obtained from SpO2 pediatric probe, after IV cannula insertion
SpO2-2
Time frame: It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, after IV cannula insertion.
Body Temperature-2
Time frame: It is going to be measured in the last 5 minutes period of the study(approximately in the 13th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Body temperature, data obtained from tympanic temperature, after IV cannula insertion
3 secondary outcomes
11-point Verbal Numeric Rating Scale-1 (VNS-1)
Time frame: It is going to be measured in the third minute(3rd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
Visual Analog Scales
Time frame: It is going to be measured in the in the last 5 minutes period of the study(approximately in the 14th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
11-point Verbal Numeric Rating Scale-2 (VNS-2)
Time frame: It is going to be measured in the in the last 5 minutes period of the study(approximately in the 15th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.
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 25 Aug 2020.
- Background: PubMed 28130888Cozzi G, Borrometi F, Benini F, Neri E, Rusalen F, Celentano L, Zanon D, Schreiber S, Ronfani L, Barbi E. First-time success with needle procedures was higher with a warm lidocaine and tetracaine patch than an eutectic mixture of lidocaine and prilocaine cream. Acta Paediatr. 2017 May;106(5):773-778. doi: 10.1111/apa.13764. Epub 2017 Feb 21.
- Background: PubMed 22679540Kim WO, Song BM, Kil HK. Efficacy and safety of a lidocaine/tetracaine medicated patch or peel for dermatologic procedures: a meta-analysis. Korean J Anesthesiol. 2012 May;62(5):435-40. doi: 10.4097/kjae.2012.62.5.435. Epub 2012 May 24.
- 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.
Ferda F Kartufan, Asst.Prof. principal investigator
Yeditepe University Anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xylocaine 10% Oral in people with Cannula Site Pain and Local Anesthesia, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 25 Aug 2020. 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 Turkey (Türkiye). 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.
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?
Heart Rate-1 (time frame: It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246255, which also lists 2 linked publications.
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 25 Aug 2020.