Injection Pain PreventionPhase 4NCT03974633
Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
A Phase 4 study testing Injection in people with Injection Pain Prevention, run by Enrique Salmeron at 1 site in Spain.
Trial summary
Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injection Pain Prevention
- What is being tested?
- Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2018to 1 May 2019
- 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
- Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study
Who cannot join
- Subjects younger than 18
- Subjects that suffered from any local or systemic sensitivity alteration
- Subjects that suffered from any cognitive deficit
- Individuals allergic to any of the components of the anesthetic ointment EMLA (eutectic mixture of lidocaine 2,5% and prilocaine 2,5%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method.
In this study, the investigators evaluated the effectivity of three non-invasive analgesic techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead injections, in a series of 100 healthy volunteers.
Read the detailed description
This study is a randomized, controlled, simple-blind clinical trial, and it has been approved by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included 100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La Fe, Valencia.
The procedures of the study consisted in the sequential performance of four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization. Injections always started from the right side of the forehead to the left. The non-invasive analgesic methods utilized were:
- Control zone: None
- Vibration: Application of the vibrating device on the skin below the injection site, before and during injection.
- Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds prior to performing the injection.
- Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes, before injection.
- Conditions
- Injection Pain Prevention
- Being tested
- Injection
- Keywords
- Analgesia, Cryoanalgesia, Vibration analgesia, Local anesthetic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionCombination product
All information is included in the Arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, without administering any type of non-invasive analgesic Receives: Combination Product: Injection |
| Vibration | Experimental | A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, while applicating a vibrating device on the skin below the injection site, before and during injection. Receives: Combination Product: Injection |
| Cold | Experimental | A subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds Receives: Combination Product: Injection |
| Anesthetic cream | Experimental | subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes Receives: Combination Product: Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain referred per each zone injected: VAS
Pain measured through a Visual Analogic Scale with values from 0 to 10; being 0 complete absence of pain, and 10 the worst pain ever experienced.
Measured: 1 hour max
Secondary outcomes (2)
Discomfort associated to non-invasive analgesic techniques
Discomfort associated to non-invasive analgesic techniques. Direct question in the survey in which answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream)
Measured: 1 hour max
Preference of non-invasive analgesic technique
Preference of non-invasive analgesic technique. Direct question in the survey in which possible answer options were each one of the non-invasive analgesic techniques (Cold, VIbration, Anesthetic cream)
Measured: 1 hour max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start24 Feb 2018
- Primary completion22 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Injection Pain PreventionStudies 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
- Crossover
- Model description
- All subjects received four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead, 2cm above the eyebrows, with a 29G needle, after applying each one of the 4 non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrique Salmeron
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrique Salmeron, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Enrique Salmeron-Gonzalez, MD, Principal investigator, University and Polytechnic Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974633
- Sponsor's protocol ID
- 2018/0547
- Status last verified
- Aug 2019
- First submitted
- 28 May 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x.
PubMed 20883298Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
PubMed 26957683Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.
PubMed 23985640Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
PubMed 20483194Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
PubMed 8169463Elibol O, Ozkan B, Hekimhan PK, Caglar Y. Efficacy of skin cooling and EMLA cream application for pain relief of periocular botulinum toxin injection. Ophthalmic Plast Reconstr Surg. 2007 Mar-Apr;23(2):130-3. doi: 10.1097/IOP.0b013e318030459c.
PubMed 17413628Simons FE, Gillespie CA, Simons KJ. Local anaesthetic creams and intradermal skin tests. Lancet. 1992 May 30;339(8805):1351-2. doi: 10.1016/0140-6736(92)91994-j. No abstract available.
PubMed 1350007
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
- ClinicalTrials.gov ID
- NCT03974633
- Acronym / sponsor ID
- 2018/0547
- Conditions
- Injection Pain Prevention
- Keywords
- Analgesia, Cryoanalgesia, Vibration analgesia, Local anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Enrique SalmeronUniversity, hospital or other
- Study start
- 24 Feb 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 5 Jun 2019 (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.
Injections are associated to a certain level of pain which tolerance can vary between individuals. As regards non-invasive pain control techniques in subcutaneous injections, scarce literature exists with adequate levels of evidence and design quality to support any specific analgesic method.
In this study, the investigators evaluated the effectivity of three non-invasive analgesic techniques (cold, anesthetic cream and vibration) when performing subcutaneous forehead injections, in a series of 100 healthy volunteers.
Detailed description
This study is a randomized, controlled, simple-blind clinical trial, and it has been approved by the Ethics Committee of the Medical Research Institute Hospital La Fe. The study included 100 healthy volunteered, and it was performed in the University and Polytechnic Hospital La Fe, Valencia.
The procedures of the study consisted in the sequential performance of four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead of each subject, 2cm above the eyebrows, with a 29G needle, after applying any of the non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization. Injections always started from the right side of the forehead to the left. The non-invasive analgesic methods utilized were:
- Control zone: None
- Vibration: Application of the vibrating device on the skin below the injection site, before and during injection.
- Cold: Application of a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds prior to performing the injection.
- Anesthetic cream: Application of a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes, before injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- All subjects received four injections of 0,1mL of physiologic saline (0,9%NaCl) in the forehead, 2cm above the eyebrows, with a 29G needle, after applying each one of the 4 non-invasive anesthetic methods studied in the trial, except for the control zone. The anesthetic method utilized in each part of the forehead of each patient was randomized through simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Combination Product: InjectionA subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, without administering any type of non-invasive analgesic |
| Vibration | Experimental | Combination Product: InjectionA subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, while applicating a vibrating device on the skin below the injection site, before and during injection. |
| Cold | Experimental | Combination Product: InjectionA subcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a bag of 50mL of frozen physiologic saline covered with a plastic glove on the injection site for 50 seconds |
| Anesthetic cream | Experimental | Combination Product: Injectionsubcutaneous injection of 0,1mL saline (0,9%NaCl) was administered in a part of the forehead, after applicating a uniform thickness of 2mm of the anesthetic cream EMLA covered with an adhesive transparent plastic dressing for 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study
Key exclusion criteria (4 listed)
- Subjects younger than 18
- Subjects that suffered from any local or systemic sensitivity alteration
- Subjects that suffered from any cognitive deficit
- Individuals allergic to any of the components of the anesthetic ointment EMLA (eutectic mixture of lidocaine 2,5% and prilocaine 2,5%).
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 |
|---|---|---|
| InjectionAll information is included in the Arm/group descriptions | Combination product | Anesthetic cream, Cold, Control, Vibration |
Primary outcome
Pain referred per each zone injected: VAS
Time frame: 1 hour max
Pain measured through a Visual Analogic Scale with values from 0 to 10; being 0 complete absence of pain, and 10 the worst pain ever experienced.
2 secondary outcomes
Discomfort associated to non-invasive analgesic techniques
Time frame: 1 hour max
Preference of non-invasive analgesic technique
Time frame: 1 hour max
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 22 Aug 2019.
- Background: PubMed 20883298Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x.
- Background: PubMed 26957683Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
- Background: PubMed 23985640Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.
- Background: PubMed 20483194Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
- Background: PubMed 8169463Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.
- Background: PubMed 17413628Elibol O, Ozkan B, Hekimhan PK, Caglar Y. Efficacy of skin cooling and EMLA cream application for pain relief of periocular botulinum toxin injection. Ophthalmic Plast Reconstr Surg. 2007 Mar-Apr;23(2):130-3. doi: 10.1097/IOP.0b013e318030459c.
- Background: PubMed 1350007Simons FE, Gillespie CA, Simons KJ. Local anaesthetic creams and intradermal skin tests. Lancet. 1992 May 30;339(8805):1351-2. doi: 10.1016/0140-6736(92)91994-j. No abstract available.
- 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.
Enrique Salmeron-Gonzalez, MD principal investigator
University and Polytechnic Hospital La Fe
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 Injection in people with Injection Pain Prevention, run by Enrique Salmeron at 1 site in Spain.
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 1 inclusion and 4 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 22 Aug 2019. 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 Spain. 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?
Pain referred per each zone injected: VAS (time frame: 1 hour max). 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 NCT03974633, which also lists 7 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 22 Aug 2019.