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Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy

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ClinicalTrials.gov Identifier: NCT02743104
Recruitment Status : Suspended (Protocol being reconsidered)
First Posted : April 19, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE April 10, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Overall Pulmonologist's satisfaction level (VAS) [ Time Frame: 2 years ]
Assessed via visual analog scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • Amount of airway secretions [ Time Frame: 2 years ]
    Assessed via visual analog scale
  • Cough score [ Time Frame: 2 years ]
    Assessed via visual analog scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
Official Title  ICMJE Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
Brief Summary The purpose of this study is to determine whether ketamine or propofol, drugs used for procedural sedation during paediatric bronchoscopy, results in higher operator satisfaction and better side effect profile.
Detailed Description

Pediatric bronchoscopy requires moderate to deep sedation in order to maintain patient comfort and safety, while optimizing the working environment for the physician performing the procedure. There is a paucity of pediatric research in the field of pediatric flexible bronchoscopy and data are often extrapolated from adult studies.

Propofol is often used as the sedation drug for this procedure due to its rapid sedative effect and favorable emergence profile. Propofol's major limitation is its tendency to cause apneas, which can occur in a relatively narrow therapeutic window. Apnea risk decreases with the patient's age and administering physician's familiarity and experience with the drug.

Ketamine is a drug often used for pediatric procedural sedation. Its pharmacologic safety profile is very wide, allowing a wide spectrum of dosing with a significantly reduced risk of apnea when compared to propofol. Known adverse effects of the drug include its emergence profile which may be accompanied by hallucinations, bronchorrhea and laryngospasm. Hallucinations may be prevented by using benzodiazepines concurrently and are possibly more pronounced in teenaged children compared to infants, although post-sedation irritability in the latter group might be an expression of this. Bronchorrhea, while usually not of significant concern during procedural sedation, has the potential to play a more noteworthy role during bronchoscopy. Significant airway secretions can create a difficult working environment for the pulmonologist performing the procedure. Patient safety may also be affected, as increased airway secretions reduce visibility in pediatric airways that are narrow to begin with and further compromised by placement of the bronchoscope. Potentially, this might also impact on the child's air flow and gas exchange. Laryngospasm during the procedure potentially hinders passage of the scope beyond the vocal cords and might extend the duration of the procedure.

In the investigators' center, propofol has most often been the sedative drug of choice for bronchoscopy. Yet, ketamine has been used at times due to its safety profile and the administering physicians level of comfort with each drug.

Aim:

To compare operator satisfaction and adverse effects in children presenting for flexible bronchoscopy using ketamine versus propofol as the primary sedative agent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Paediatric Flexible Bronchoscopy
Intervention  ICMJE
  • Drug: Ketamine
    Other Name: Ketalar
  • Drug: Propofol
    Other Name: Diprivan
  • Drug: midazolam and atropine
  • Drug: Lidocaine
Study Arms  ICMJE
  • Active Comparator: Ketamine for procedural sedation

    All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg.

    This study group will be exposed to ketamine as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.

    Interventions:
    • Drug: Ketamine
    • Drug: midazolam and atropine
    • Drug: Lidocaine
  • Active Comparator: Propofol for procedural sedation

    All patients will be sedated according to a written protocol which includes intravenous administration of midazolam and atropine. In addition, local anesthesia will be performed using lidocaine 1% sprayed once just above the vocal cords, and again at the level of the carina. Lidocaine doses are limited to a maximum total dose of 5mg/kg.

    This study group will be exposed to propofol as the main drug for sedation, as an initial bolus of 1-2 mg/kg initially and then titrated by additional doses of 1mg/kg per dose.

    Interventions:
    • Drug: Propofol
    • Drug: midazolam and atropine
    • Drug: Lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 18, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children undergoing flexible bronchoscopy

Exclusion Criteria:

  • Failure to acquire parental consent
  • Bronchoscopies performed outside of the bronchoscopy suite
  • Bronchoscopies performed under general anesthesia with a protected airway
  • Bronchoscopies performed by personnel outside of the study group
  • Known allergies to either of the sedation drugs used
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02743104
Other Study ID Numbers  ICMJE KP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Group data will be published. No individual data will be made available.
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP