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Completed

NCT Number: NCT02050152

Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222-2006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 6-12 years old,
  • ASA classification: 1 and 2
  • Elective surgery

Exclusion criteria

  • Uncooperative child needs sedation before induction of anesthesia
  • Developmental delay, ADHD, autism, Tourette's syndrome, schizophrenia, congenital and acquired brain disorder, Down syndrome.
  • Those who request for IV induction
  • Those taking sedative medications, anti-seizure medication
  • Those with malignant hyperthermia, muscular dystrophy; those with uncorrected cardiac defects and those with severe or active lung disease
  • Those with elective admissions to PICU with ongoing sedation and tracheal intubation

Treatment and study plan

Nitrous Oxide 0%

Drug

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

Other names: Placebo

Nitrous oxide 33%

Drug

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

Other names: low concentration Nitrous oxide

Nitrous oxide 66%

Drug

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

Other names: high concentration Nitrous oxide

Primary outcomes

  1. Explicit Memory

    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

    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.

Secondary outcomes

  1. Explicit Memory

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

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

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

    Time frame: 2 hours after anesthesia

    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

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

    Time frame: 2 hours after anesthesia

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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2014
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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