NCT05579288

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 13, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

September 22, 2022

Last Update Submit

October 11, 2022

Conditions

Pain AlleviationDilatation and EvacuationLaminaria PlacementNitrous Oxide

Keywords

Pain AlleviationDilatation and EvacuationLaminaria PlacementNitrous Oxide

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Secondary Outcomes (1)

  • Self-report of change in maximal pain during the procedure

    2 days

Study Arms (2)

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.

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.

Drug: Oxygen (O2)

Interventions

Nitrous oxide (N2O/O2)DRUG

Nitrous oxide (N2O/O2) for pain alleviation

Study Arm
Oxygen (O2)DRUG

Oxygen (O2) as placebo for control group

Control Arm

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (10)

  • 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.

    PMID: 20687085BACKGROUND

  • Meyer 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.

    PMID: 32652092BACKGROUND

  • Wood 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.

    PMID: 20151606BACKGROUND

  • Burnweit 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.

    PMID: 15017577BACKGROUND

  • Young 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.

    PMID: 22524905BACKGROUND

  • Broughton 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.

    PMID: 33408580BACKGROUND

  • Descamps 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.

    PMID: 17911025BACKGROUND

  • O'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.

    PMID: 12748131BACKGROUND

  • Schneider 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.

    PMID: 27621048BACKGROUND

  • Mercier 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.

    PMID: 25139724BACKGROUND

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Nitrous OxideOxygen

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsChalcogensElements

Central Study Contacts

Shlomi Toussia-Cohen, MD

CONTACT

+97235302772shloms83@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 13, 2022

Study Start

December 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

October 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)