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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection | Combination Product | All information is included in the Arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour max |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour max |
| Preference of non-invasive analgesic technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Salmeron-Gonzalez, MD | University and Polytechnic Hospital La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University and Polytechnic Hospital La Fe | Valencia | 46026 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20883298 | Background | 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. | |
| 26957683 | Background | Davoudi 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 | Aug 19, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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.
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Outcomes were studied by an investigator that did not participate in the practical part of the trial.
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) |
| 1 hour max |
| 23985640 | Background | Strazar 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. |
| 20483194 | Background | Taddio 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. |
| 8169463 | Background | Ernst 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. |
| 17413628 | Background | Elibol 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. |
| 1350007 | Background | Simons 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |