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Emergence ReactionNCT02145169

Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study

A study testing Inhaled Nitrous Oxide in people with Emergence Reaction and Procedural Sedation, run by Albert Einstein Healthcare Network at 1 site in United States.

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

To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Emergence Reaction, Procedural Sedation
What is being tested?
Inhaled Nitrous Oxide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2013to Apr 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion criteria: All spontaneously breathing subjects, 18 years of age and older, with an American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an ED procedure. Written informed consent will be obtained from all subjects.

Exclusion criteria: Subjects with underlying conditions that could affect ventilation, perfusion, or metabolism including intubated subjects, subjects with clinical signs of cardiopulmonary instability, major trauma, thoracic trauma, shock, sepsis, psychiatric disorders and ASA class 3, 4, and 5. Also those unable to provide informed consent, nursing home residents, age less than 18 years, non English speaking, pregnant women, subjects under police custody, or physician discretion.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

Other trials in United States

About this study

To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.

Read the detailed description

Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases.

Ketamine hydrochloride is a phencyclidine derivative that causes dissociation between the cortical and limbic systems preventing the higher centers from perceiving visual, auditory, or painful stimuli. It possesses a rapid onset and short duration of action and produces profound sedation and analgesia. Ketamine is also a non-competitive NMDA antagonist, which complements NO. However, laryngeal reflexes are maintained and respiratory depression is rare. These properties have made ketamine a very popular agent for procedural sedation and analgesia in pediatric emergency department patients . Unfortunately, when given to adult patients, it frequently causes emergence anxiety, nightmares, hallucinations, and delirium. These emergence reactions have limited the use of ketamine in adults. The incidence of these reactions is about 7-10% in children. Emergence reactions may be a product of the state in which the patient becomes disassociated . Therefore, if the patient is more relaxed prior to ketamine administration through the adjunct use of NO, adverse emergence reactions may be reduced.

A number of agents including diazepam, lorazepam, fentanyl, droperidol, and others have been used with varying success to reduce or prevent emergence reactions associated with ketamine use. Diazepam and lorazepam have been the most successful, but their use may prolong recovery time, making them less desirable in the emergency department setting. Midazolam has been shown to lower the rate of emergence reaction when used concurrently with ketamine in adults. However, like all benzodiazepines, there is a small risk of respiratory depression and hypoxia with the use of midazolam, which could lead to an adverse respiratory event.

Inhaled nitrous oxide may be an ideal adjunct to the prevention of emergence reaction in adults being treated with ketamine. Nitrous oxide is a colorless gas that diffuses rapidly across the pulmonary alveoli providing analgesia and anxiolysis with minimal sedative effects, rapid induction, and emergence. Nitrous oxide is a weak sedative agent with the potential for significant analgesic effects. Noncompetitive antagonist activity at the NMDA receptor along with activation of opioid receptors contributes to its anesthetic mechanism. There are rare adverse events, most often cited as case reports of chronic or acute toxicity causing myeloneuropathies and polyneuropathies.

Nitrous oxide has been used in general anesthesia for over 2 centuries, but its use outside of the operating room began when Tunstall introduced the nitrous oxide/oxygen mixture as an analgesic agent during labor. Since this inception, the nitrous oxide/oxygen mixture has been used readily in the fields of dentistry, gastrointestinal procedures, and children's procedural sedation. Nitrous oxide is often administrated via continuous flow or on-demand at a concentration of 50-70%.

There is some early data describing a favorable adverse event profile with nitrous oxide as a single agent in adults. Hennequin et al. demonstrated support for the efficacy of nitrous oxide with no major adverse cardio respiratory events. Although approximately 10% of participants received mild gastrointestinal and behavioral side effects (e.g. agitation). Greater than 90% of the study participants stated they would receive nitrous oxide again. In a large prospective trial, Babl et al. found there to be only 2 patients out of 655 who suffered serious adverse events (i.e., chest pain and oxygen desaturation). Both patients had been administered 70% nitrous oxide compared to the more conservative 50% concentration. Additionally, there was an increased incidence of minor adverse events (i.e., emesis and agitation) with the higher concentration of nitrous oxide. Kariman et al. compared nitrous oxide versus parental fentanyl as an analgesic after long bone fracture and found similar pain scores and a more rapid decrease in the pain score in the nitrous oxide group when compared with the opiate group.

Nitrous oxide has been shown to be a safe and effective agent for procedural sedation in children, including work that has combined opiates and benzodiazepines with nitrous continuously. Burton et al. conducted a small, randomized controlled trial studying the effectiveness of nitrous oxide on anxiety scores in children during laceration repairs. They found a significant decrease in the group that used nitrous oxide compared to the placebo group. This finding was further validated by Luhmann et al. with 50% continuous flow nitrous oxide resulting in less distress and anxiety as well as increased patient satisfaction compared to midazolam or topical anesthetic agents. The study also showed that the main adverse event associated with nitrous oxide was nausea and vomiting, whereas midazolam group had significant ataxia and dizziness. There was no demonstrable advantage of the combination of midazolam and nitrous oxide in regard to patient satisfaction versus nitrous oxide alone, but there was an increase in adverse events when midazolam was included.

A study performed by Evans et al. demonstrated that the pain and memory of the procedure between children receiving either nitrous oxide versus children receiving intramuscular meperidine in combination with promethazine for fracture reduction was similar, but there was increased satisfaction and decreased length of stay in the nitrous oxide group. Seith et al. demonstrated that the addition of intranasal fentanyl to nitrous oxide in children resulted in deeper levels of sedation when compared to nitrous oxide alone; however, there were no serious adverse events.

Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, we believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.

Since this is a novel concept, we believe that a pilot study to evaluate the safety and efficacy of 50/50 nitrous oxide/oxygen administration with adult ketamine administration is warranted.

Being tested
Inhaled Nitrous Oxide
Keywords
procedural sedation, emergence reaction, nitrous oxide, ketamine

What participants receive

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

  • Inhaled Nitrous OxideDrug

    Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide

Study groups in NCT02145169
Study groupRoleWhat they receive
Nitrous Oxide armExperimentalPatients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask
Receives: Drug: Inhaled Nitrous Oxide

What is being measured

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

  1. Emergence Reaction

    Presence or absence of emergence reaction

    Measured: At primary ED visit when the patient is undergoing the intervention

Secondary outcomes (12)
  1. Physiologic Measure

    ETCO2 measured q 5 seconds

    Measured: At primary ED visit when the patient is undergoing the intervention

  2. Physiologic Measure

    SpO2 measured q 5 seconds

    Measured: At primary ED visit when the patient is undergoing the intervention

  3. Vitals

    heart rate, respiratory rate, peripheral SaO2

    Measured: At primary ED visit when the patient is undergoing the intervention

  4. Physician Interventions

    verbal or physical stimulation, airway repositioning, additional oxygen, positive pressure ventilation, endotracheal intubation

    Measured: At primary ED visit when the patient is undergoing the intervention

  5. Level of Sedation

    Ramsay sedation score

    Measured: At primary ED visit when the patient is undergoing the intervention

  6. Patient Recall of Procedure

    Patient recall of procedure

    Measured: At primary ED visit when the patient is undergoing the intervention

  7. Total Ketamine Dose

    Total Ketamine dose

    Measured: At primary ED visit when the patient is undergoing the intervention

  8. Total Time of Nitrous Use

    Total elapsed time of nitrous use

    Measured: At primary ED visit when the patient is undergoing the intervention

  9. Physician Procedure Satisfaction Score

    Physician procedure satisfaction survey responses

    Measured: At procedure completion

  10. Patient Procedure Satisfaction Score

    Patient procedure satisfaction survey responses

    Measured: At procedure completion

  11. Nurse Procedure Satisfaction Score

    Nurse procedure satisfaction survey responses

    Measured: At procedure completion

  12. Length of ED Stay

    Length of ED stay

    Measured: At primary ED visit

Timeline

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

  1. First posted22 May 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145169
Sponsor's protocol ID
HN4507FBD
Status last verified
Dec 2016
First submitted
9 May 2014
Last updated
19 Mar 2020
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Inhaled Nitrous Oxide in people with Emergence Reaction and Procedural Sedation, run by Albert Einstein Healthcare Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 19 Mar 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Emergence Reaction (time frame: At primary ED visit when the patient is undergoing the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Mar 2020.

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