Health TrialsbyHealthPanel

Vapocoolant Spray to Reduce Pain With Nexplanon Insertion

ConditionReducing Pain With Nexplanon Implant Insertion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14+
SponsorQueen's Medical Center

About this trial

The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 14 years or older

Undergoing an etonogestrel implant insertion in the arm in POB1 Suite 1004 or POB2 Suite 402

English speaking

Able and willing to sign the informed consent form and agree to terms of the study

Disqualifiers

Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure

Known previous exposure to vapocoolant spray

Nexplanon removal and reinsertion same day during visit in the same arm

Contraindications to vapocoolant spray components (ethyl chloride and 1,1,1,3,3-pentafluoropropane/1,1,1,2-tetrafluroethane)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vapocoolant spray

    Device

    Pain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first.

  • Placebo

    Other intervention

    Nature's Tears will be applied to the arm as a placebo spray

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Vapocoolant SprayExperimental treatment 1 intervention
Group B: Nature's TearsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain with lidocaine injection

The investigators will ask patients to rate their pain with lidocaine injection that precedes Nexplanon insertion using a visual analog scale (VAS). The visual analog scale is a 100 mm line, with values 0 to 100. 0 is marked as no pain and 100 is marked as worst pain.

Time frame
Immediately after lidocaine injection

Secondary outcomes

1

Patient satisfaction

Patients will be asked about their satisfaction with pain control for the procedure and satisfaction for the procedure overall using a survey with 5 options, including very unsatisfied, unsatisfied, neutral, satisfied, and very satisfied.

Time frame
Immediately after procedure
2

Pain Reduction with Remainder of Procedure

Participants will be asked to rate their pain using a visual analog scale (VAS) in regard to pain when the implant was inserted. The visual analog scale is a 100 mm line, with values 0 to 100. 0 is marked as no pain and 100 is marked as worst pain.They will also be asked about their pain for the procedure overall using a Likert scale from 0 (no pain) to 10 (severe pain).

Time frame
Immediately after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen's Medical Center

Lead sponsor

Lakshmi Devi and Devraj Sharma Endowment

Collaborator

Source ClinicalTrials.gov
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