Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy

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

Tracking Information

• First Submitted Date: April 10, 2016
• First Posted Date: April 19, 2016
• Last Update Posted Date: April 28, 2017
• Study Start Date: May 2016
• Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2016)

Overall Pulmonologist's satisfaction level (VAS) [ Time Frame: 2 years ]

Assessed via visual analog scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Paediatric Flexible Bronchoscopy

Intervention

• Drug: Ketamine
  Other Name: Ketalar
• Drug: Propofol
  Other Name: Diprivan
• Drug: midazolam and atropine
• Drug: Lidocaine

Study Arms

• 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 *

• Hwang J, Jeon Y, Park HP, Lim YJ, Oh YS. Comparison of alfetanil and ketamine in combination with propofol for patient-controlled sedation during fiberoptic bronchoscopy. Acta Anaesthesiol Scand. 2005 Oct;49(9):1334-8.
• Dal T, Sazak H, Tunç M, Sahin S, Yılmaz A. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study. J Thorac Dis. 2014 Jun;6(6):742-51. doi: 10.3978/j.issn.2072-1439.2014.04.10.
• Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
• Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60.

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: April 18, 2016): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2019
• Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02743104
• Other Study ID Numbers: KP-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Rabin Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rabin Medical Center
• Verification Date: April 2016