Evaluation of Three Non-invasive Analgesic Techniques in Pain Prevention During Injections

NCT03974633 | Completed Phase 4

• 1 other identifier: 2018/0547
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Injection Pain Prevention

Keywords

Analgesia; Cryoanalgesia; Vibration analgesia; Local anesthetic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Discomfort associated to non-invasive analgesic techniques

  1 hour max

• Preference of non-invasive analgesic technique

  1 hour max

Study Arms (4)

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

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.

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

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

Combination Product: Injection

Interventions

Injection COMBINATION_PRODUCT

All information is included in the Arm/group descriptions

Anesthetic cream; Cold; Control; Vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Enrique Salmeron: lead

Study Sites (1)

University and Polytechnic Hospital La Fe

Valencia, 46026, Spain

Location

Related Publications (7)

• 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.

  PMID: 20883298 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.

  PMID: 26957683 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.

  PMID: 23985640 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.

  PMID: 20483194 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.

  PMID: 8169463 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.

  PMID: 17413628 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.

  PMID: 1350007 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Injections

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Enrique Salmeron-Gonzalez, MD

  University and Polytechnic Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes were studied by an investigator that did not participate in the practical part of the trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 5, 2019
• Study Start: February 24, 2018
• Primary Completion: April 22, 2019
• Study Completion: May 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)