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CompletedNCT02050152Updated Jun 30, 2026Results posted

Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

An interventional study of Nitrous Oxide 0% and Nitrous oxide 33% in Amnesia, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

The investigators are conducting a study to investigate the amnestic effects of 2 different concentrations of nitrous oxide in children before induction of anesthesia in a prospective double-blinded placebo controlled study.

Read the detailed description

Children of age group 6-12 will be randomly divided in 3 groups, First group will be Placebo , second group will be nitrous oxide end tidal 33% and third group will be nitrous oxide 66%. Each group will be divided into 2 subgroups randomly with either a flavored or unflavored mask for induction.

All children will be told a joke before the mask is applied, with the answer provided after the end-tidal nitrous oxide concentration reaches the randomized concentration (0, 33 or 66%) for at least one minute. At that point, the child will randomized to be either shown a picture of one of four animals (predetermined randomly) or a food will be stated aloud. For the animal, the child will be asked to name the animal aloud. The child's response (yes or no to a response and whether the item is correctly named) will be recorded. If the child does not respond, the name of the animal will be stated out loud. For the food, one of four foods will be named aloud and child will be asked to repeat the name. The child's response (named or not) will be recorded. Anesthesia will continue with the designated nitrous oxide concentration combined with 8% Sevoflurane.

When the child is ready for discharge from the recovery room and recovered from anesthesia, a nurse or doctor who is blinded to the treatment group assignment will ask the child to recall the joke and answer. The child will then be asked if they were shown any animals and if so, which animal? If the child cannot recall an animal, the child will be asked to name the first animal that comes to mind. The child will then be shown pictures of four animals and asked to identify one. The child will be asked if they heard any foods when they went to sleep? If the child cannot recall hearing any foods recited, the first letter of the food will be shown: B _ _ _ _ _ . If the child does not recall any foods, then the child will be given the names of four foods that begin with the letter B and asked to pick one. Finally, the child will be asked about any odors in the mask during anesthesia. If he/she does not recall, then four odors will be read out and the child asked to identify any one. Additionally, the children will be asked whether they recall any odors on the mask as they were anesthetized. The order of items questioned in the recovery period will follow the same order as in the OR.

02

Conditions studied

  • Amnesia

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Keywords

  • Amnesia
  • Memory
  • Implicit
  • Explicit
  • Nitrous Oxide
03

In context

Amnesia

22 studies on the registry are indexed under Amnesia; 2 are open to participants now.

This study's enrollment of 90 is above the median of 62 across 19 interventional studies indexed under Amnesia.

Browse Amnesia studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 6-12 years old,
  2. : 1 and 2
  3. Elective surgery

Exclusion criteria

Exclusion Criteria:

  1. Uncooperative child needs sedation before induction of anesthesia
  2. Developmental delay, ADHD, autism, Tourette's syndrome, schizophrenia, congenital and acquired brain disorder, Down syndrome.
  3. Those who request for IV induction
  4. Those taking sedative medications, anti-seizure medication
  5. Those with malignant hyperthermia, muscular dystrophy; those with uncorrected cardiac defects and those with severe or active lung disease
  6. Those with elective admissions to PICU with ongoing sedation and tracheal intubation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Nitrous oxide 0%

    Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling jokes.

    Drug: Nitrous Oxide 0%

  • Active comparator
    Nitrous oxide 33%

    Nitrous oxide 33% for 2 minutes while showing pictures and telling jokes.

    Drug: Nitrous oxide 33%

  • Active comparator
    Nitrous oxide 66%

    Nitrous oxide 66% for 2 minutes while showing pictures and telling jokes.

    Drug: Nitrous oxide 66%

Interventions

  • DrugNitrous Oxide 0%

    Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask

    Also known as: Placebo

  • Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask

    Also known as: low concentration Nitrous oxide

  • Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask

    Also known as: high concentration Nitrous oxide

06

What researchers measure

Primary outcomes

  1. Explicit Memory

    Explicit memory will be tested during the recovery period (once the child has fully recovered from anesthesia but before discharge from hospital) by a blinded observer who will ask the child whether they smelled za bad odor while they breathed through the mask.

    Time frame: After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed

Secondary outcomes

  1. Explicit Memory

    Explicit memory will be tested for the child recalling the riddle and answer after the study

    Time frame: After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion

  2. Explicit Memory if the Child Remembered Being Shown an Animal in a Photo

    The child will be shown the photo of an animal while they were breathing through the mask and then asked to recall which animal they were shown in the photo during the mask induction

    Time frame: 2 hours after anesthesia

  3. Explicit Memory of the Name of a Food That Begins With the Letter "b"

    The child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask

    Time frame: 2 hours after anesthesia

07

Results

Posted Jun 30, 2026

Participant flow

Participant flow — Overall Study
Milestone0% Nitrous Oxide30% Nitrous Oxide60% Nitrous Oxide
Started302931
Completed302931
Not completed000

Outcome measures

PrimaryExplicit Memory

Explicit memory will be tested during the recovery period (once the child has fully recovered from anesthesia but before discharge from hospital) by a blinded observer who will ask the child whether they smelled za bad odor while they breathed through the mask.

Time frame:
After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed
Reported as:
Number · participants
Explicit Memory
participantsNitrous Oxide 0%Nitrous Oxide 33%Nitrous Oxide 66%
Explicit Memory712
SecondaryExplicit Memory

Explicit memory will be tested for the child recalling the riddle and answer after the study

Time frame:
After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion
Reported as:
Count of participants · Participants
Explicit Memory
Participants0% N2O33% N2O60% N2O
Explicit Memory212114
SecondaryExplicit Memory if the Child Remembered Being Shown an Animal in a Photo

The child will be shown the photo of an animal while they were breathing through the mask and then asked to recall which animal they were shown in the photo during the mask induction

Time frame:
2 hours after anesthesia
Reported as:
Count of participants · Participants
Explicit Memory if the Child Remembered Being Shown an Animal in a Photo
Participants0% N2O33% N2O60% N2O
Explicit Memory if the Child Remembered Being Shown an Animal in a Photo272114
SecondaryExplicit Memory of the Name of a Food That Begins With the Letter "b"

The child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask

Time frame:
2 hours after anesthesia
Reported as:
Count of participants · Participants
Explicit Memory of the Name of a Food That Begins With the Letter "b"
ParticipantsExplicit Recall a Food That Started With a "b" With 0% N2OExplicit Recall a Food That Started With a "b" With 33% N2OExplicit Recall a Food That Started With a "b" With 66% N2O
Explicit Memory of the Name of a Food That Begins With the Letter "b"10157

Adverse events

Collected over During the day of surgery, 1 day.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nitrous Oxide 0%0/30 (0%)0/30 (0%)0/30 (0%)
Nitrous Oxide 30%0/29 (0%)0/29 (0%)0/29 (0%)
Nitrous Oxide 60%0/31 (0%)0/31 (0%)0/31 (0%)

Baseline characteristics

Children 6-12 years, ASA physical status 1 or 2

Age, Continuous
Age, Continuous(years)0% Nitrous Oxide30% Nitrous Oxide60% Nitrous OxideTotal
Mean8.3 ± 1.98.2 ± 1.68.2 ± 1.98.2 ± 1.8
Sex: Female, Male
Sex: Female, Male(Participants)0% Nitrous Oxide30% Nitrous Oxide60% Nitrous OxideTotal
Female15231755
Male1561435
Region of Enrollment
Region of Enrollment(participants)0% Nitrous Oxide30% Nitrous Oxide60% Nitrous OxideTotal
United States30293190
08

Study locations

1 site
  • Women and Children's Hospital of Buffalo
    Buffalo, New York 14222-2006, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02050152
Responsible party
Jerrold Lerman (Clinical Professor of Anesthesiology, State University of New York at Buffalo) — Principal investigator
First posted
Jan 30, 2014
Start date
May 2013
Primary completion
Oct 2013
Completion
Oct 2013
Results posted
Jun 30, 2026
Last update
Jun 30, 2026

Study contacts

Jerrold Lerman, MD, FRCPC
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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