Pain AlleviationEarly Phase 1NCT05579288
Use of Nitrous Oxide for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Dilatation and Evacuation
A Early Phase 1 study testing Nitrous oxide (N2O/O2) and Oxygen (O2) in people with Pain Alleviation and Dilatation and Evacuation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
A randomised control study aiming to examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation with osmotic dilators (laminaria) alleviates pain and is superior to placebo. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Alleviation, Dilatation and Evacuation, Laminaria Placement
- What is being tested?
- Nitrous oxide (N2O/O2) and Oxygen (O2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2022to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Informed consent
Who cannot join
- D\&E due to PPROM or infection.
- Known N2O allergy.
- Contraindication to N2O use - Congenital heart defects, pulmonary hypertension, megaloblastic anemia, O2 blood saturation <95%
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan
Shlomi Toussia-Cohen, MD, shloms83@gmail.com
About this study
Official title: Use of Nitrous Oxide for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
A randomised control study aiming to examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation with osmotic dilators (laminaria) alleviates pain and is superior to placebo.
Read the detailed description
Introduction:
Women undergoing second trimester abortion often undergo preparation of the cervix prior to the Dilatation and Evacuation (D\&E). Women may undergo preparation with osmotic dilators (laminaria) or prostaglandins, both methods are effective and safe for cervical preparation(1). In our institution, the protocol for cervical preparation in the second trimester with osmotic dilator insertion takes place 24 hours before the procedure in the gynecologic emergency room/clinic. Currently, the protocol does not include any method of pain relief during the cervix preparation procedure.
At this time, besides general anesthesia, there are no satisfactory evidence-based methods for pain alleviation for osmotic dilators insertion. For example, a recent randomized controlled trial showed topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo(2).
Inhaled nitrous oxide administered with oxygen (N2O/O2) is an acceptable, effective and widely used method for pain relief in short painful pediatric ,dental and urologic procedures(3-5), as well as in the labor room and in the emergency room(6, 7). N2O/O2 has analgesic, anxiolytic and amnestic properties. N2O/O2 has rapid onset and reversal with minimal side effects and few contraindications. Side effects of N2O/O2 are relatively minor and include nausea, dizziness, drowsiness, light-headedness, and diaphoresis. Contraindications include congenital heart defects, pulmonary hypertension, megaloblastic anemia and relatively low blood O2 saturation (<95%)(8, 9).
A recent randomized controlled trial showed inhaled N2O/O2 is associated with less pain compared to oral sedation for pain management during in-office hysteroscopic sterilization(9) To the best of our knowledge, there is no literature regarding the efficacy of use of nitrous oxide for pain alleviation in women undergoing osmotic dilator insertion for second trimester Dilatation and Evacuation.
Goal:
To examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to placebo.
Methods:
A prospective randomized placebo-controlled trial consisting of two groups:
Inhaled N2O/O2 (group 1) Placebo group (O2 only) (group 2)
Women undergoing dilatation and evacuation in the second trimester and are about to undergo cervical dilatation with osmotic dilators (laminaria) will be invited to participate in a randomized placebo control trial comparing Inhaled N2O/O2 or placebo (O2 only).
The recruitment and trial will take place in the emergency room/clinic where the women come a day before the D\&E for cervical preparation. This procedure is routinely performed in a gynecologic chair without any sedation thus assessing pain scores is possible.
Informed consent will be obtained from each participant. Randomization will be performed using a computer randomization generator. After enrollment, patients will be randomized into one of the two study arms. allocation to the two treatment groups will be concealed in sequentially numbered opaque envelopes that will be opened only by the nurse actually administering the gas (either inhaled N2O/O2 or inhaled oxygen). The participant and physician will be completely blinded to the intervention.
Participants will be asked about their most severe pain during menses and asked to rate it from 0 to 10.
The patient will be placed in the lithotomy position.
Group1: Patients will receive inhaled N2O/O2 (70% N2O and 30% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled N2O/O2 will be stopped after speculum removal.
Group2: Patients will receive inhaled O2 (100% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled O2 will be stopped after speculum removal.
Patients will receive inhaled O2 (100% O2) throughout the procedure until speculum removal.
Pain will be assessed at 7-time intervals using a visual analog pain scale 0 (no pain) to 100 (worst possible pain) - 1.Prior to mask application, 2. Before speculum insertion, 3. Immediately after speculum insertion, 4. Immediately after insertion of first laminaria, 5. Immediately after insertion of last laminaria, 6. After speculum removal (including actual VAS and recall of maximal VAS during the procedure), 7. Before the D\&E the next day.
Satisfaction with the procedure will be collected as well- overall satisfaction (0-100) and satisfaction with pain control (0-100).
Data regarding adverse events will be collected as well.
Primary outcome:
Self-report of pain score immediately following speculum removal.
Secondary outcome:
Self-report of maximal pain during the procedure.
The protocol will not be repeated if a participant is to return for further laminaria insertion.
- Being tested
- Nitrous oxide (N2O/O2), Oxygen (O2)
- Keywords
- Pain Alleviation, Dilatation and Evacuation, Laminaria Placement, Nitrous Oxide
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxide (N2O/O2)Drug
Nitrous oxide (N2O/O2) for pain alleviation
Oxygen (O2)Drug
Oxygen (O2) as placebo for control group
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Patients will receive inhaled N2O/O2 (70% N2O and 30% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled N2O/O2 will be stopped after speculum removal. Receives: Drug: Nitrous oxide (N2O/O2) |
| Control Arm | Placebo comparator | Patients will receive inhaled O2 (100% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled O2 will be stopped after speculum removal.
Patients will receive inhaled O2 (100% O2) throughout the procedure until speculum removal. Receives: Drug: Oxygen (O2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report of change in pain score immediately following speculum removal
Pain will be assessed at 7-time intervals using a visual analog pain scale 0 (no pain) to 100 (worst possible pain) - 1.Prior to mask application, 2. Before speculum insertion, 3. Immediately after speculum insertion, 4. Immediately after insertion of first laminaria, 5. Immediately after insertion of last laminaria, 6. After speculum removal (including actual VAS and recall of maximal VAS during the procedure), 7. Before the D\&E the next day.
Measured: 2 days
Secondary outcomes (1)
Self-report of change in maximal pain during the procedure
Pain will be assessed at 7-time intervals using a visual analog pain scale 0 (no pain) to 100 (worst possible pain) - 1.Prior to mask application, 2. Before speculum insertion, 3. Immediately after speculum insertion, 4. Immediately after insertion of first laminaria, 5. Immediately after insertion of last laminaria, 6. After speculum removal (including actual VAS and recall of maximal VAS during the procedure), 7. Before the D\&E the next day.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain AlleviationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579288
- Sponsor's protocol ID
- SHEBA-22-8935-ST-CTIL
- Status last verified
- Apr 2022
- First submitted
- 22 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007310. doi: 10.1002/14651858.CD007310.pub2.
PubMed 20687085Meyer R, Cahan T, Yagel I, Afek A, Derazne E, Bar-Shavit Y, Yuval Y, Admon D, Shina A. A double-blind randomized trial comparing lidocaine spray and placebo spray anesthesia prior to cervical laminaria insertion. Contraception. 2020 Nov;102(5):332-338. doi: 10.1016/j.contraception.2020.07.002. Epub 2020 Jul 8.
PubMed 32652092Wood M. The safety and efficacy of intranasal midazolam sedation combined with inhalation sedation with nitrous oxide and oxygen in paediatric dental patients as an alternative to general anaesthesia. SAAD Dig. 2010 Jan;26:12-22.
PubMed 20151606Burnweit C, Diana-Zerpa JA, Nahmad MH, Lankau CA, Weinberger M, Malvezzi L, Smith L, Shapiro T, Thayer K. Nitrous oxide analgesia for minor pediatric surgical procedures: an effective alternative to conscious sedation? J Pediatr Surg. 2004 Mar;39(3):495-9; discussion 495-9. doi: 10.1016/j.jpedsurg.2003.11.037.
PubMed 15017577Young A, Ismail M, Papatsoris AG, Barua JM, Calleary JG, Masood J. Entonox(R) inhalation to reduce pain in common diagnostic and therapeutic outpatient urological procedures: a review of the evidence. Ann R Coll Surg Engl. 2012 Jan;94(1):8-11. doi: 10.1308/003588412X13171221499702.
PubMed 22524905Broughton K, Clark AG, Ray AP. Nitrous Oxide for Labor Analgesia: What We Know to Date. Ochsner J. 2020 Winter;20(4):419-421. doi: 10.31486/toj.19.0102.
PubMed 33408580Descamps MJ, Gwilym S, Weldon D, Holloway V. Prospective audit of emergency department transit times associated with entonox analgesia for reduction of the acute, traumatic dislocated shoulder. Accid Emerg Nurs. 2007 Oct;15(4):223-7. doi: 10.1016/j.aaen.2007.07.008. Epub 2007 Oct 29.
PubMed 17911025O'Sullivan I, Benger J. Nitrous oxide in emergency medicine. Emerg Med J. 2003 May;20(3):214-7. doi: 10.1136/emj.20.3.214.
PubMed 12748131Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
PubMed 27621048Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
PubMed 25139724
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nitrous Oxide for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
- ClinicalTrials.gov ID
- NCT05579288
- Acronym / sponsor ID
- SHEBA-22-8935-ST-CTIL
- Keywords
- Pain Alleviation, Dilatation and Evacuation, Laminaria Placement, Nitrous Oxide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
A randomised control study aiming to examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation with osmotic dilators (laminaria) alleviates pain and is superior to placebo.
Detailed description
Introduction:
Women undergoing second trimester abortion often undergo preparation of the cervix prior to the Dilatation and Evacuation (D\&E). Women may undergo preparation with osmotic dilators (laminaria) or prostaglandins, both methods are effective and safe for cervical preparation(1). In our institution, the protocol for cervical preparation in the second trimester with osmotic dilator insertion takes place 24 hours before the procedure in the gynecologic emergency room/clinic. Currently, the protocol does not include any method of pain relief during the cervix preparation procedure.
At this time, besides general anesthesia, there are no satisfactory evidence-based methods for pain alleviation for osmotic dilators insertion. For example, a recent randomized controlled trial showed topical application of lidocaine spray to the cervix before insertion did not result in lower reported pain as compared with placebo(2).
Inhaled nitrous oxide administered with oxygen (N2O/O2) is an acceptable, effective and widely used method for pain relief in short painful pediatric ,dental and urologic procedures(3-5), as well as in the labor room and in the emergency room(6, 7). N2O/O2 has analgesic, anxiolytic and amnestic properties. N2O/O2 has rapid onset and reversal with minimal side effects and few contraindications. Side effects of N2O/O2 are relatively minor and include nausea, dizziness, drowsiness, light-headedness, and diaphoresis. Contraindications include congenital heart defects, pulmonary hypertension, megaloblastic anemia and relatively low blood O2 saturation (<95%)(8, 9).
A recent randomized controlled trial showed inhaled N2O/O2 is associated with less pain compared to oral sedation for pain management during in-office hysteroscopic sterilization(9) To the best of our knowledge, there is no literature regarding the efficacy of use of nitrous oxide for pain alleviation in women undergoing osmotic dilator insertion for second trimester Dilatation and Evacuation.
Goal:
To examine whether inhaled N2O/O2 during cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to placebo.
Methods:
A prospective randomized placebo-controlled trial consisting of two groups:
Inhaled N2O/O2 (group 1) Placebo group (O2 only) (group 2)
Women undergoing dilatation and evacuation in the second trimester and are about to undergo cervical dilatation with osmotic dilators (laminaria) will be invited to participate in a randomized placebo control trial comparing Inhaled N2O/O2 or placebo (O2 only).
The recruitment and trial will take place in the emergency room/clinic where the women come a day before the D\&E for cervical preparation. This procedure is routinely performed in a gynecologic chair without any sedation thus assessing pain scores is possible.
Informed consent will be obtained from each participant. Randomization will be performed using a computer randomization generator. After enrollment, patients will be randomized into one of the two study arms. allocation to the two treatment groups will be concealed in sequentially numbered opaque envelopes that will be opened only by the nurse actually administering the gas (either inhaled N2O/O2 or inhaled oxygen). The participant and physician will be completely blinded to the intervention.
Participants will be asked about their most severe pain during menses and asked to rate it from 0 to 10.
The patient will be placed in the lithotomy position.
Group1: Patients will receive inhaled N2O/O2 (70% N2O and 30% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled N2O/O2 will be stopped after speculum removal.
Group2: Patients will receive inhaled O2 (100% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled O2 will be stopped after speculum removal.
Patients will receive inhaled O2 (100% O2) throughout the procedure until speculum removal.
Pain will be assessed at 7-time intervals using a visual analog pain scale 0 (no pain) to 100 (worst possible pain) - 1.Prior to mask application, 2. Before speculum insertion, 3. Immediately after speculum insertion, 4. Immediately after insertion of first laminaria, 5. Immediately after insertion of last laminaria, 6. After speculum removal (including actual VAS and recall of maximal VAS during the procedure), 7. Before the D\&E the next day.
Satisfaction with the procedure will be collected as well- overall satisfaction (0-100) and satisfaction with pain control (0-100).
Data regarding adverse events will be collected as well.
Primary outcome:
Self-report of pain score immediately following speculum removal.
Secondary outcome:
Self-report of maximal pain during the procedure.
The protocol will not be repeated if a participant is to return for further laminaria insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Drug: Nitrous oxide (N2O/O2)Patients will receive inhaled N2O/O2 (70% N2O and 30% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled N2O/O2 will be stopped after speculum removal. |
| Control Arm | Placebo comparator | Drug: Oxygen (O2)Patients will receive inhaled O2 (100% O2). A sterile bivalve speculum will be placed. Laminaria will be inserted. Inhaled O2 will be stopped after speculum removal. Patients will receive inhaled O2 (100% O2) throughout the procedure until speculum removal. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Informed consent
Key exclusion criteria (3 listed)
- D\&E due to PPROM or infection.
- Known N2O allergy.
- Contraindication to N2O use - Congenital heart defects, pulmonary hypertension, megaloblastic anemia, O2 blood saturation <95%
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 |
|---|---|---|
| Nitrous oxide (N2O/O2)Nitrous oxide (N2O/O2) for pain alleviation | Drug | Study Arm |
| Oxygen (O2)Oxygen (O2) as placebo for control group | Drug | Control Arm |
Primary outcome
Self-report of change in pain score immediately following speculum removal
Time frame: 2 days
Pain will be assessed at 7-time intervals using a visual analog pain scale 0 (no pain) to 100 (worst possible pain) - 1.Prior to mask application, 2. Before speculum insertion, 3. Immediately after speculum insertion, 4. Immediately after insertion of first laminaria, 5. Immediately after insertion of last laminaria, 6. After speculum removal (including actual VAS and recall of maximal VAS during the procedure), 7. Before the D\&E the next day.
1 secondary outcome
Self-report of change in maximal pain during the procedure
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 20687085Newmann SJ, Dalve-Endres A, Diedrich JT, Steinauer JE, Meckstroth K, Drey EA. Cervical preparation for second trimester dilation and evacuation. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007310. doi: 10.1002/14651858.CD007310.pub2.
- Background: PubMed 32652092Meyer R, Cahan T, Yagel I, Afek A, Derazne E, Bar-Shavit Y, Yuval Y, Admon D, Shina A. A double-blind randomized trial comparing lidocaine spray and placebo spray anesthesia prior to cervical laminaria insertion. Contraception. 2020 Nov;102(5):332-338. doi: 10.1016/j.contraception.2020.07.002. Epub 2020 Jul 8.
- Background: PubMed 20151606Wood M. The safety and efficacy of intranasal midazolam sedation combined with inhalation sedation with nitrous oxide and oxygen in paediatric dental patients as an alternative to general anaesthesia. SAAD Dig. 2010 Jan;26:12-22.
- Background: PubMed 15017577Burnweit C, Diana-Zerpa JA, Nahmad MH, Lankau CA, Weinberger M, Malvezzi L, Smith L, Shapiro T, Thayer K. Nitrous oxide analgesia for minor pediatric surgical procedures: an effective alternative to conscious sedation? J Pediatr Surg. 2004 Mar;39(3):495-9; discussion 495-9. doi: 10.1016/j.jpedsurg.2003.11.037.
- Background: PubMed 22524905Young A, Ismail M, Papatsoris AG, Barua JM, Calleary JG, Masood J. Entonox(R) inhalation to reduce pain in common diagnostic and therapeutic outpatient urological procedures: a review of the evidence. Ann R Coll Surg Engl. 2012 Jan;94(1):8-11. doi: 10.1308/003588412X13171221499702.
- Background: PubMed 33408580Broughton K, Clark AG, Ray AP. Nitrous Oxide for Labor Analgesia: What We Know to Date. Ochsner J. 2020 Winter;20(4):419-421. doi: 10.31486/toj.19.0102.
- Background: PubMed 17911025Descamps MJ, Gwilym S, Weldon D, Holloway V. Prospective audit of emergency department transit times associated with entonox analgesia for reduction of the acute, traumatic dislocated shoulder. Accid Emerg Nurs. 2007 Oct;15(4):223-7. doi: 10.1016/j.aaen.2007.07.008. Epub 2007 Oct 29.
- Background: PubMed 12748131O'Sullivan I, Benger J. Nitrous oxide in emergency medicine. Emerg Med J. 2003 May;20(3):214-7. doi: 10.1136/emj.20.3.214.
- Background: PubMed 27621048Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
- Background: PubMed 25139724Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nitrous oxide (N2O/O2) and Oxygen (O2) in people with Pain Alleviation and Dilatation and Evacuation, run by Sheba Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shlomi Toussia-Cohen, MD (+97235302772, shloms83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of change in pain score immediately following speculum removal (time frame: 2 days). 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 NCT05579288, which also lists 10 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 2022.