Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

NCT02050152 | Completed Results

• 1 other identifier: Nitrous Oxide Amnesia Children
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amnesia

Keywords

Amnesia; Memory; Implicit; Explicit; Nitrous Oxide

Outcome Measures

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.

  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 (3)

• Explicit Memory

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

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

  2 hours after anesthesia

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

  2 hours after anesthesia

Study Arms (3)

Nitrous oxide 0%

PLACEBO COMPARATOR

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

Drug: Nitrous Oxide 0%

Nitrous oxide 33%

ACTIVE COMPARATOR

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

Drug: Nitrous oxide 33%

Nitrous oxide 66%

ACTIVE COMPARATOR

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

Drug: Nitrous oxide 66%

Interventions

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

Also known as: Placebo

Nitrous oxide 0%

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

Also known as: low concentration Nitrous oxide

Nitrous oxide 33%

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

Also known as: high concentration Nitrous oxide

Nitrous oxide 66%

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222-2006, United States

Location

MeSH Terms

Conditions

Amnesia

Condition Hierarchy (Ancestors)

Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jerrold Lerman, Clinical Professor of Anesthesiology
• Organization: Women and Children's Hospital of Buffalo, SUNY at Buffalo

jlerman@buffalo.edu

716-878-7701

Study Officials

• Jerrold Lerman, MD, FRCPC

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: January 30, 2014
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)