NCT06595303

Brief Summary

  1. 1.Background to the clinical research project Nitrous oxide is a valuable tool in medicine for its rapid and effective analgesic and sedative properties. It is used in 50% gaseous form for painful procedures. One frequent application is obstetric analgesia. However, in addition to its analgesic effects, many articles mention the psychotropic, even psychedelic, effects of nitrous oxide use. In one of the most recent studies, entitled More than just joy: A qualitative analysis of participant experiences during nitrous oxide sedation, involving healthy volunteers, it is reported that the sensations and feelings of the subjects are not necessarily pleasant, and many volunteers report psychedelic-like sensations, dreams or disturbed perceptions. The authors then question whether these effects are due to an absence of painful stimuli and therefore an absence of a beneficial effect. The same effects have been reported by Atkinson et al, also on volunteer subjects. Parturients feelings are highly variable, with a stronger focus on analgesic efficacy.
  2. 2.Objectives of the clinical research project 2.1 Primary objective: The main objective will be to evaluate the effects of nitrous oxide, other than analgesia, in the specific context of childbirth. The study will focus mainly on subjective feelings, as well as the effects of disconnection from reality.
  3. 3.Methodology of the clinical research project All patients who have received nitrous oxide for delivery as part of the standard course of treatment in the delivery room will be contacted within 24 hours by one of the investigators. The protocol, i.e. the questionnaire, will be explained to the patients and, if they accept the protocol, written consent will be obtained. Patients will then complete the questionnaire in the presence of one of the investigators, who will be able to explain the questions if necessary. The questionnaire will take around 20 minutes to complete.
  4. 4.Design of the clinical research project Prospective study based on a questionnaire.
  5. 5.Participants Any person who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the informed consent form for this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

September 10, 2024

Last Update Submit

May 20, 2025

Conditions

Keywords

Nitrous oxidelabour analgesia

Outcome Measures

Primary Outcomes (1)

  • Unpleasant psychotropic effects

    Percentage (%) of patients who report an unpleasant psychotropic effect during nitrous oxide administration for labour analgesia.

    12 hours

Secondary Outcomes (1)

  • Analgesic effect

    12 hours

Study Arms (1)

N2O for labour analgesia

Any woman who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the informed consent form for this study.

Drug: Nitrous oxide for labour analgesia

Interventions

Any woman may choose to have nitrous oxide inhalation as a standard protocol for labour analgesia

N2O for labour analgesia

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in labour
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any woman who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the consent form for this study.

You may qualify if:

  • Any person who received nitrous oxide for childbirth at Hôpital Érasme between October 1, 2024 and April 30, 2025 and who signed the informed consent form for this study.

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.U.B - Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (10)

  • Carles G. [Pregnancy, delivery and customs: transcultural approach in obstetrics]. J Gynecol Obstet Biol Reprod (Paris). 2014 Apr;43(4):275-80. doi: 10.1016/j.jgyn.2013.12.002. Epub 2014 Jan 17. French.

    PMID: 24440128BACKGROUND
  • Waldenstrom U, Hildingsson I, Rubertsson C, Radestad I. A negative birth experience: prevalence and risk factors in a national sample. Birth. 2004 Mar;31(1):17-27. doi: 10.1111/j.0730-7659.2004.0270.x.

    PMID: 15015989BACKGROUND
  • Richardson MG, Raymond BL, Baysinger CL, Kook BT, Chestnut DH. A qualitative analysis of parturients' experiences using nitrous oxide for labor analgesia: It is not just about pain relief. Birth. 2019 Mar;46(1):97-104. doi: 10.1111/birt.12374. Epub 2018 Jul 22.

    PMID: 30033596BACKGROUND
  • Valtonen P, Markkanen S, Jarventausta K, Tenhunen M, Kalliomaki ML. More than just joy: A qualitative analysis of participant experiences during nitrous oxide sedation. Acta Anaesthesiol Scand. 2024 Aug;68(7):906-912. doi: 10.1111/aas.14428. Epub 2024 Apr 9.

    PMID: 38594960BACKGROUND
  • Atkinson RM, Green JD, Chenoweth DE, Atkinson JH. Subjective effects of nitrous oxide: cognitive, emotional, perceptual and transcendental experiences. J Psychedelic Drugs. 1979 Oct-Dec;11(4):317-30. doi: 10.1080/02791072.1979.10471415. No abstract available.

    PMID: 522172BACKGROUND
  • Block RI, Ghoneim MM, Kumar V, Pathak D. Psychedelic effects of a subanesthetic concentration of nitrous oxide. Anesth Prog. 1990 Nov-Dec;37(6):271-6.

    PMID: 2097905BACKGROUND
  • Migliaccio L, Lawton R, Leeman L, Holbrook A. Initiating Intrapartum Nitrous Oxide in an Academic Hospital: Considerations and Challenges. J Midwifery Womens Health. 2017 May;62(3):358-362. doi: 10.1111/jmwh.12635. Epub 2017 May 29.

    PMID: 28556573BACKGROUND
  • Moon JS, Kuza CM, Desai MS. William James, Nitrous Oxide, and the Anaesthetic Revelation. J Anesth Hist. 2018 Jan;4(1):1-6. doi: 10.1016/j.janh.2017.10.012. Epub 2017 Dec 1.

    PMID: 29559088BACKGROUND
  • Kronenberg G, Seifritz E, Olbrich S. Nitrous oxide inhalation: History and experiences. Acta Anaesthesiol Scand. 2024 Sep;68(8):1129. doi: 10.1111/aas.14462. Epub 2024 May 30. No abstract available.

    PMID: 38815989BACKGROUND
  • Husum B, Stenqvist O, Alahuhta S, Sigurdsson GH, Dale O. Current use of nitrous oxide in public hospitals in Scandinavian countries. Acta Anaesthesiol Scand. 2013 Oct;57(9):1131-7. doi: 10.1111/aas.12165. Epub 2013 Jul 29.

    PMID: 23889322BACKGROUND

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

November 5, 2024

Primary Completion

May 15, 2025

Study Completion

May 20, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations