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Nitrous OxideNCT06595303

Nitrous Oxyde During Labour

An observational study of Nitrous Oxide and Labour Analgesia, run by Erasme University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Nitrous Oxide, Labour Analgesia
What is being tested?
Nitrous oxide for labour analgesia
How many people
70 participants
Where
1 siteBelgium
Study dates
5 Nov 2024to 20 May 2025
Phase
Observational
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • No informed consent

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • H.U.B - Hôpital Erasme

    Brussels, 1070

Other trials in Belgium

About this study

Official title: Feelings of Patients Who Received Nitrous Oxide During Childbirth

  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. 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. 2.2 Secondary objectives: As secondary objectives, we will study the efficacy on pain.
  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. Design of the clinical research project Prospective study based on a questionnaire.
  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.
Being tested
Nitrous oxide for labour analgesia
Keywords
Nitrous oxide, labour analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitrous oxide for labour analgesiaDrug

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

Study groups in NCT06595303
Study groupRoleWhat they receive
N2O for labour analgesiaAny 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.
Receives: Drug: Nitrous oxide for labour analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unpleasant psychotropic effects

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

    Measured: 12 hours

Secondary outcomes (1)

  1. Analgesic effect

    All patients will report the analgesic efficiency of nitrous oxide during labour analgesia using a 3 point scale (very effective - somewhat effective - no effect). Percentage (%) of each effect will be presented.

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start5 Nov 2024
  3. Primary completion15 May 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595303
Sponsor's protocol ID
SRB2024218
Status last verified
May 2025
First submitted
10 Sep 2024
Last updated
21 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24440128

  • 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.

    PubMed 15015989

  • 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.

    PubMed 30033596

  • 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.

    PubMed 38594960

  • 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.

    PubMed 522172

  • 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.

    PubMed 2097905

  • 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.

    PubMed 28556573

  • 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.

    PubMed 29559088

  • 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.

    PubMed 38815989

  • 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.

    PubMed 23889322

Questions about this trial

What is this clinical trial studying?

An observational study of Nitrous Oxide and Labour Analgesia, run by Erasme University Hospital at 1 site in Belgium.

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 1 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: finished, as of the sponsor's last update on 21 May 2025. 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 Belgium. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unpleasant psychotropic effects (time frame: 12 hours). 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 NCT06595303, 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 21 May 2025.

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