Reducing Pain With Nexplanon Implant InsertionNCT06933381
Vapocoolant Spray to Reduce Pain With Nexplanon Insertion
A study testing Vapocoolant spray in people with Reducing Pain With Nexplanon Implant Insertion, run by Queen's Medical Center at 3 sites in United States.
Trial summary
The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reducing Pain With Nexplanon Implant Insertion
- What is being tested?
- Vapocoolant spray
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Unable to provide written, informed consent in English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Queens Medical Center POB 2 Suite 402
Honolulu, Hawaii, 96813
Sarah Murayama, MD, 808-783-0298, smura@hawaii.edu
Mary Tschann, PhD, 808-375-3785
- Recruiting
Queens Medical Center POB1 Clinic 1004
Honolulu, Hawaii, 96813
Sarah Murayama, MD, 808-783-0298, smura@hawaii.edu
Mary Tschann, PhD, 808-375-3785, mtschann@hawaii.edu
- Not yet recruiting
Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120
Waimea, Hawaii, 96743
Bliss Kaneshiro, MD, MPH, 808-372-7560, blissk@hawaii.edu
Bliss Kaneshiro, MD, MPH
About this study
Official title: Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.
Read the detailed description
This study will be for patients in the office having a Nexplanon (etonogestrel implant) insertion. The doctor in clinic will evaluate if a patient meets eligibility criteria for this study. If the patient meets eligibility criteria, the doctor will inform the patient of the study and the potential risks. If patients elect to participate, a research coordinator will obtain written informed consent. The patient will be randomized (patient is blinded) to receive either Pain Ease vapocoolant spray or placebo (normal saline) spray. They will receive the spray just before lidocaine injection during the Nexplanon insertion procedure. The purpose of the study is to see if Pain Ease vapocoolant spray reduces patient pain during lidocaine injection for Nexplanon insertion.
- Being tested
- Vapocoolant spray, Placebo
- Keywords
- Vapocoolant spray, Pain with Nexplanon insertion, Contraceptive implant insertion, Vapocoolant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vapocoolant sprayDevice
Also called Pain Ease
Pain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first.
PlaceboOther
Also called Nature's Tears
Nature's Tears will be applied to the arm as a placebo spray
| Study group | Role | What they receive |
|---|---|---|
| Vapocoolant Spray | Experimental | This is the study arm. Participants in this arm of the study will receive Pain Ease vapocoolant spray during their Nexplanon implant insertion in the arm. They will receive the spray on their arm right before lidocaine injection is administered for Nexplanon insertion procedure. Pain Ease vapocoolant spray is FDA approved for use on skin prior to common needle-stick procedures like intravenous (IV) starts and vaccines. The investigators will use the spray in a similar fashion, to help with the pain of lidocaine injection during Nexplanon insertion procedures. Physicians will do the Nexplanon procedure before any other procedures if patient has multiple procedures scheduled the same day. Receives: Device: Vapocoolant spray |
| Nature's Tears | Placebo comparator | This is the placebo. This group will receive Nature's Tears, which is a saline spray that does not offer analgesic effects. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after lidocaine injection
Secondary outcomes (2)
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.
Measured: Immediately after procedure
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).
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start16 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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 Reducing Pain With Nexplanon Implant InsertionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lakshmi Devi and Devraj Sharma Endowment
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933381
- Sponsor's protocol ID
- RA-2025-007
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
PubMed 8604867Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.
PubMed 26979261Unal N, Tosun B, Aslan O, Tunay S. Effects of Vapocoolant Spray Prior to SC LMWH Injection: An Experimental Study. Clin Nurs Res. 2021 Feb;30(2):127-134. doi: 10.1177/1054773818825486. Epub 2019 Jan 30.
PubMed 30698458Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.
PubMed 30253890Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.
PubMed 26162573Wilson GA, Jeter JW, Dabbs WS, Stevens AB, Heidel RE, Chamberlin SM. Comparison of traditional anesthesia method and jet injector anesthesia method (MadaJet XL(R)) for Nexplanon(R) insertion and removal. Contracept Reprod Med. 2020 Feb 24;5:1. doi: 10.1186/s40834-020-00104-x. eCollection 2020.
PubMed 32123573Bentsianov SD, Brandi K, Chen P, Shimoni N. A Pilot Study to Understand the Adolescent Pain Experience During Contraceptive Implant Insertion. J Pediatr Adolesc Gynecol. 2021 Aug;34(4):522-524. doi: 10.1016/j.jpag.2021.01.013. Epub 2021 Jan 27.
PubMed 33515699
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06933381
- Acronym / sponsor ID
- RA-2025-007
- Keywords
- Vapocoolant spray, Pain with Nexplanon insertion, Contraceptive implant insertion, Vapocoolant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Collaborators
- Lakshmi Devi and Devraj Sharma Endowment
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Apr 2025 (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.
The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.
Detailed description
This study will be for patients in the office having a Nexplanon (etonogestrel implant) insertion. The doctor in clinic will evaluate if a patient meets eligibility criteria for this study. If the patient meets eligibility criteria, the doctor will inform the patient of the study and the potential risks. If patients elect to participate, a research coordinator will obtain written informed consent. The patient will be randomized (patient is blinded) to receive either Pain Ease vapocoolant spray or placebo (normal saline) spray. They will receive the spray just before lidocaine injection during the Nexplanon insertion procedure. The purpose of the study is to see if Pain Ease vapocoolant spray reduces patient pain during lidocaine injection for Nexplanon insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapocoolant Spray | Experimental | Device: Vapocoolant sprayThis is the study arm. Participants in this arm of the study will receive Pain Ease vapocoolant spray during their Nexplanon implant insertion in the arm. They will receive the spray on their arm right before lidocaine injection is administered for Nexplanon insertion procedure. Pain Ease vapocoolant spray is FDA approved for use on skin prior to common needle-stick procedures like intravenous (IV) starts and vaccines. The investigators will use the spray in a similar fashion, to help with the pain of lidocaine injection during Nexplanon insertion procedures. Physicians will do the Nexplanon procedure before any other procedures if patient has multiple procedures scheduled the same day. |
| Nature's Tears | Placebo comparator | Other: PlaceboThis is the placebo. This group will receive Nature's Tears, which is a saline spray that does not offer analgesic effects. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
- Unable to provide written, informed consent in English
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 |
|---|---|---|
| Vapocoolant sprayAlso: Pain EasePain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first. | Device | Vapocoolant Spray |
| PlaceboAlso: Nature's TearsNature's Tears will be applied to the arm as a placebo spray | Other | Nature's Tears |
Primary outcome
Pain with lidocaine injection
Time frame: Immediately after 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.
2 secondary outcomes
Patient satisfaction
Time frame: Immediately after procedure
Pain Reduction with Remainder of Procedure
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 8604867Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.
- Background: PubMed 26979261Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.
- Background: PubMed 30698458Unal N, Tosun B, Aslan O, Tunay S. Effects of Vapocoolant Spray Prior to SC LMWH Injection: An Experimental Study. Clin Nurs Res. 2021 Feb;30(2):127-134. doi: 10.1177/1054773818825486. Epub 2019 Jan 30.
- Background: PubMed 30253890Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.
- Background: PubMed 26162573Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.
- Background: PubMed 32123573Wilson GA, Jeter JW, Dabbs WS, Stevens AB, Heidel RE, Chamberlin SM. Comparison of traditional anesthesia method and jet injector anesthesia method (MadaJet XL(R)) for Nexplanon(R) insertion and removal. Contracept Reprod Med. 2020 Feb 24;5:1. doi: 10.1186/s40834-020-00104-x. eCollection 2020.
- Background: PubMed 33515699Bentsianov SD, Brandi K, Chen P, Shimoni N. A Pilot Study to Understand the Adolescent Pain Experience During Contraceptive Implant Insertion. J Pediatr Adolesc Gynecol. 2021 Aug;34(4):522-524. doi: 10.1016/j.jpag.2021.01.013. Epub 2021 Jan 27.
- Gebauer's Pain EaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapocoolant spray in people with Reducing Pain With Nexplanon Implant Insertion, run by Queen's Medical Center at 3 sites in United States.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Murayama, MD (808-783-0298, smura@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with lidocaine injection (time frame: Immediately after lidocaine injection). 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 NCT06933381, 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 13 Oct 2026.