Paediatric Flexible BronchoscopyNCT02743104
Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
A study testing Ketamine, Propofol and midazolam and atropine in people with Paediatric Flexible Bronchoscopy, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Paediatric Flexible Bronchoscopy
- What is being tested?
- Ketamine, Propofol and midazolam and atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children undergoing flexible bronchoscopy
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Paediatric Flexible Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
PropofolDrug
Also called Diprivan
midazolam and atropineDrug
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketamine for procedural sedation | Active comparator | 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. Receives: Drug: Ketamine; Drug: midazolam and atropine; Drug: Lidocaine |
| Propofol for procedural sedation | Active comparator | 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. Receives: Drug: Propofol; Drug: midazolam and atropine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pulmonologist's satisfaction level (VAS)
Assessed via visual analog scale
Measured: 2 years
Secondary outcomes (2)
Amount of airway secretions
Assessed via visual analog scale
Measured: 2 years
Cough score
Assessed via visual analog scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: Protocol being reconsidered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Paediatric Flexible BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743104
- Sponsor's protocol ID
- KP-001
- Status last verified
- Apr 2016
- First submitted
- 10 Apr 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Group data will be published. No individual data will be made available.
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. doi: 10.1111/j.1399-6576.2005.00842.x.
PubMed 16146472Dal T, Sazak H, Tunc M, Sahin S, Yilmaz 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.
PubMed 24976998Wahidi 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.
PubMed 22045879Stolz 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. doi: 10.1378/chest.128.3.1756.
PubMed 16162784
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine vs Propofol for Sedation During Pediatric Bronchoscopy
- ClinicalTrials.gov ID
- NCT02743104
- Acronym / sponsor ID
- KP-001
- Conditions
- Paediatric Flexible Bronchoscopy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol being reconsidered
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine for procedural sedation | Active comparator | Drug: Ketamine, Drug: midazolam and atropine, Drug: LidocaineAll 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. |
| Propofol for procedural sedation | Active comparator | Drug: Propofol, Drug: midazolam and atropine, Drug: LidocaineAll 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children undergoing flexible bronchoscopy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketalar | Drug | Ketamine for procedural sedation |
| PropofolAlso: Diprivan | Drug | Propofol for procedural sedation |
| midazolam and atropine | Drug | Ketamine for procedural sedation, Propofol for procedural sedation |
| Lidocaine | Drug | Ketamine for procedural sedation, Propofol for procedural sedation |
Primary outcome
Overall Pulmonologist's satisfaction level (VAS)
Time frame: 2 years
Assessed via visual analog scale
2 secondary outcomes
Amount of airway secretions
Time frame: 2 years
Cough score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Background: PubMed 16146472Hwang 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. doi: 10.1111/j.1399-6576.2005.00842.x.
- Background: PubMed 24976998Dal T, Sazak H, Tunc M, Sahin S, Yilmaz 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.
- Background: PubMed 22045879Wahidi 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.
- Background: PubMed 16162784Stolz 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. doi: 10.1378/chest.128.3.1756.
- Individual participant dataSharing planned: Yes. Group data will be published. No individual data will be made available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Propofol and midazolam and atropine in people with Paediatric Flexible Bronchoscopy, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. 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: paused, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Overall Pulmonologist's satisfaction level (VAS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743104, which also lists 4 linked publications.
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 28 Apr 2017.