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Completed

NCT Number: NCT03171740

Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children

Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Brasilia University

Brasília, Federal District, 7000000, Brazil

About this study

Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for amygdalectomy
  • American Society of Anesthesiologists Physical Status PI or PII
  • Absence of congenital neuropathy
  • Absence of cardiac pathology (any)
  • Intolerance to one of the studied drugs.

Exclusion criteria

  • Protocol violation
  • Need to transfer for ICU intubated

Treatment and study plan

Dexmedetomidine

Drug

Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)

Other names: Precedex

Midazolam oral solution

Drug

Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)

Oral saline

Drug

Oral saline, 0.25ml/kg

Other names: 0.9% Saline solution

Nasal saline

Drug

Nasal saline 0.01ml/kg

Other names: 0.9% Saline solution

Primary outcomes

  1. Emergence agitation

    Time frame: 15 minutes

    Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.

Secondary outcomes

  1. Bradycardia

    Time frame: 2 hours

    It is defined as a heart rate lower than the expected for the age or a drop higher than 30% of the patient's lowest previous heart rate registered. It will be measured using pletysmography and ECG beat-by-beat during the surgery and it will be true if it occurs at least once.

  2. Hypotension

    Time frame: 2 hours

    It is defined as a mean arterial pressure lower than the expected for the age or a drop higher than 30% of the patient's lowest previous mean arterial pressure registered. It will be measured using oscillatory method every 5 minutes during the surgery and it will be true if it occurs at least once.

  3. Intraocular pressure

    Time frame: 15-minutes

    It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg.

  4. Respiratory depression

    Time frame: 30 minutes

    Anesthesiologist provider's reported incidence respiratory depression in the child, before induction of general anesthesia. It will be true if the respiratory rate is slow for the age and the variable is dichotomic (true or false).

  5. Paradoxal agitation

    Time frame: 30 minutes

    Anesthesiologist provider's reported incidence paradoxal agitation in the child, before induction of general anesthesia. The assessment subjective and the variable is dichotomic (true or false).

Sponsors and collaborators

Lead sponsor

Brasilia University Hospital

Other

Registry information

Official study title

Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 31, 2017
Registry last updated
Jul 13, 2018

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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