Nitrous Oxide for Pain Management During In-Office Gynecology Procedures

NCT06661005 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 2008947582
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. IV sedation for office-based gynecology procedures provides effective anesthesia but requires a recovery time, IV placement, and a ride provided for the patient. Nitrous oxide can be a viable alternative to IV sedation while also reducing recovery time and omitting the need for an IV, NPO status, and a ride home.

Conditions

Nitrous Oxide

Outcome Measures

Primary Outcomes (2)

• Pain Evaluation

  Post procedure, patients will be asked to rate their pain using the VASscale, with 0 indicating no pain, to 10 indicating worst possible, unbearable, excruciating pain.

  Procedure start time to procedure end time.

• Patient Satisfaction

  Post procedure, patients will be asked to rate their satisfaction using the following scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, or Very Satisfied

  Procedure start time to procedure end time.

Study Arms (2)

Nitrous Day

EXPERIMENTAL

The Nitrous group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio

Drug: Nitrous oxide

IV Sedation Day

ACTIVE COMPARATOR

The IV sedation group will receive instructions to arrive at clinic 1 hour before her procedure in order to sign consent forms and have an IV placed. She will be given instructions to remain NPO status at least 8 hours prior to the procedure and will need someone to bring her to and from the appointment. Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol.

Drug: IV Sedation

Interventions

Nitrous oxide DRUG

The Nitrous oxide group will receive instructions to arrive at clinic 30 minutes before her procedure in order to sign consent forms. She will not be given instructions to remain NPO and will not be required to have someone bring her to and from the appointment. No IV will be placed. Anesthesia induction will be done by an anesthesiologist with a nitrous oxygen mixture at a 70:30 ratio

Nitrous Day

IV Sedation DRUG

Anesthesia induction will be done by an anesthesiologist with propofol per standard protocol. A pulse oximeter will be placed and oxygen will be administered through a nasal cannula and the patient will be instructed to breath.

IV Sedation Day

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: These are female Gynecology patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Negative UPT
• English speaking,
• At the Banner Women's Institute who are consented for any of the following procedures with sedation: Diagnostic hysteroscopy, Hysteroscopic endometrial biopsy, Hysteroscopy, IUD placement, Hysteroscopic IUD removal, Colposcopy, LEEP

You may not qualify if:

• Chronic narcotic use,
• Contraindications to Nitrous oxide (i.e. Vit B12 deficiency, pulmonary disease),
• Indication for general anesthesia in the main operating room
• BMI \>40
• Non-English Speaking

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (10)

• Boyle HE. NITROUS OXIDE: HISTORY AND DEVELOPMENT. Br Med J. 1934 Jan 27;1(3812):153-5. doi: 10.1136/bmj.1.3812.153. No abstract available.

  PMID: 20778037 BACKGROUND

• Fujinaga M, Maze M. Neurobiology of nitrous oxide-induced antinociceptive effects. Mol Neurobiol. 2002 Apr;25(2):167-89. doi: 10.1385/MN:25:2:167.

  PMID: 11936558 BACKGROUND

• Goerig M, Esch JSA. History of nitrous oxide-with special reference to its early use in Germany. Best Practice & Research Clinical Anaesthesiology. 2001;15(3):313-338.

  BACKGROUND

• Huang C, Johnson N. Nitrous Oxide, From the Operating Room to the Emergency Department. Curr Emerg Hosp Med Rep. 2016;4:11-18. doi: 10.1007/s40138-016-0092-3. Epub 2016 Mar 22.

  PMID: 27073749 BACKGROUND

• Jevtovic-Todorovic V, Todorovic SM, Mennerick S, Powell S, Dikranian K, Benshoff N, Zorumski CF, Olney JW. Nitrous oxide (laughing gas) is an NMDA antagonist, neuroprotectant and neurotoxin. Nat Med. 1998 Apr;4(4):460-3. doi: 10.1038/nm0498-460.

  PMID: 9546794 BACKGROUND

• Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.

  PMID: 25596171 BACKGROUND

• Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.

  PMID: 18813051 BACKGROUND

• 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: 27621048 BACKGROUND

• Singh RH, Thaxton L, Carr S, Leeman L, Schneider E, Espey E. A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women. Int J Gynaecol Obstet. 2016 Nov;135(2):145-148. doi: 10.1016/j.ijgo.2016.04.014. Epub 2016 Jul 16.

  PMID: 27481016 BACKGROUND

• Smith W. Under the influence. A history of nitrous oxide and oxygen Anesthesia. Park Ridge: The Wood Library Museum of Anesthesiology; 1982

  BACKGROUND

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be consented for the study at their office visit when the decision is made to schedule them for a procedure meeting inclusion criteria for our study. After the patient is consented, they will be randomized to either nitrous oxide or IV sedation. Depending on their randomization group, they will be scheduled on a "Nitrous Day" or an "IV Sedation Day".

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: May 17, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)