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

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ClinicalTrials.gov Identifier: NCT03974633
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Enrique Salmeron, Instituto de Investigacion Sanitaria La Fe

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.


Condition or disease Intervention/treatment Phase
Injection Pain Prevention Combination Product: Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: Outcomes were studied by an investigator that did not participate in the practical part of the trial.
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial Evaluating Three Non-invasive Analgesic Techniques in Pain Prevention During Injections
Actual Study Start Date : February 24, 2018
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : May 1, 2019

Arm Intervention/treatment
Placebo Comparator: Control
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
All information is included in the Arm/group descriptions

Experimental: Vibration
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
All information is included in the Arm/group descriptions

Experimental: Cold
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
All information is included in the Arm/group descriptions

Experimental: Anesthetic cream
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
All information is included in the Arm/group descriptions




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Discomfort associated to non-invasive analgesic techniques [ Time Frame: 1 hour max ]
    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)

  2. Preference of non-invasive analgesic technique [ Time Frame: 1 hour max ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Every subject who did not meet any of the exclusion criteria, and signed the informed consent, was included in the study

Exclusion Criteria:

  • 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%).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974633


Locations
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Spain
University and Polytechnic Hospital La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Enrique Salmeron
Investigators
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Principal Investigator: Enrique Salmeron-Gonzalez, MD University and Polytechnic Hospital La Fe
  Study Documents (Full-Text)

Documents provided by Enrique Salmeron, Instituto de Investigacion Sanitaria La Fe:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Enrique Salmeron, Principal Investigator, Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT03974633     History of Changes
Other Study ID Numbers: 2018/0547
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enrique Salmeron, Instituto de Investigacion Sanitaria La Fe:
Analgesia
Cryoanalgesia
Vibration analgesia
Local anesthetic

Additional relevant MeSH terms:
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Anesthetics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents