Sickle Cell DiseasePhase 3NCT04150757
Intranasal Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the PED
A Phase 3 study testing Intranasal ketamine in people with Sickle Cell Disease and Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by Abigail Nixon at 2 sites in United States.
Trial summary
This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement. Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- Intranasal ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2019to 1 Jun 2022
- Phase
- Phase 3
- 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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of Hemoglobin SS or SC disease
- Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5
- Parent or patient willing to provide consent/assent
- English speaking
Who cannot join
- Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation
- Allergy to ketamine
- GCS<15
- Obstructive nasal anatomy as per parent history
- History of a psychiatric disorder
- Pregnant patients will be excluded. Female patients > 12 years old are routinely tested for pregnancy in our PED. Patients found to be pregnant will not be enrolled in study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center
The Bronx, New York, 10461
JACOBI
The Bronx, New York, 10461
About this study
Official title: The Use of Intranasal (IN) Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the Pediatric Emergency Department
This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.
Read the detailed description
This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.
- Conditions
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis, Ketamine, Intranasal Ketamine, Analgesia
- Being tested
- Intranasal ketamine
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal ketamineDrug
Patients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement.
| Study group | Role | What they receive |
|---|---|---|
| Standard Analgesia | No intervention | Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control. |
| Intranasal Ketamine + Standard Analgesia | Active comparator | Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). Receives: Drug: Intranasal ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Measured: 30 minutes
Change in Pain Score Using Numeric Rating Scale (age>11yr)
Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. For patients 11 yrs and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
Measured: 30 minutes
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Measured: 15 minutes
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. For patients older than 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
Measured: 15 minutes
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Measured: 15 minutes
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. For patients 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
Measured: 15 minutes
Secondary outcomes (4)
Additional Opiate Medication
Number of opiate analgesic doses and a comparison of opiate equivalents/kilogram versus mean dose for prior visits (if the patient has been seen for VOE prior)
Measured: Duration of ED visit, an average of 5 hrs
Patient Satisfaction
Patient/Parent satisfaction based on questionnaire. Patients will answer based on a 4 point scale (not happy at all/a little happy/happy\&satisfied/very happy)
Measured: At patient disposition, an average of 5 hrs
Rate of Admission
Percentage of patients within each group who are admitted (vs discharged)
Measured: Duration of ED visit, an average of 5 hrs
Rate of Return Visit
Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start19 Dec 2019
- Primary completion1 Oct 2020
- Study completion1 Jun 2022
Why it stopped: Poor recruitment secondary to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). This is an observational study.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abigail Nixon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abigail Nixon, New York City Health and Hospitals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150757
- Sponsor's protocol ID
- 2019-10379
- Other IDs
- 2019
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2019
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intranasal (IN) Ketamine for Pain Control in Patients with Sickle Cell Disease and Vaso-occlusive Episode (VOE) in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT04150757
- Acronym / sponsor ID
- 2019-10379
- Conditions
- Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis, Ketamine, Intranasal Ketamine, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment secondary to COVID
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abigail NixonUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.
Detailed description
This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). This is an observational study.
| Arm | Type | Receives |
|---|---|---|
| Standard Analgesia | No intervention | –Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control. |
| Intranasal Ketamine + Standard Analgesia | Active comparator | Drug: Intranasal ketamineEnrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- History of Hemoglobin SS or SC disease
- Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5
- Parent or patient willing to provide consent/assent
- English speaking
Key exclusion criteria (6 listed)
- Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation
- Allergy to ketamine
- GCS<15
- Obstructive nasal anatomy as per parent history
- History of a psychiatric disorder
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 |
|---|---|---|
| Intranasal ketaminePatients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement. | Drug | Intranasal Ketamine + Standard Analgesia |
Primary outcome
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Time frame: 30 minutes
Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Change in Pain Score Using Numeric Rating Scale (age>11yr)
Time frame: 30 minutes
Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. For patients 11 yrs and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Time frame: 15 minutes
Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Time frame: 15 minutes
Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. For patients older than 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
Change in Pain Score Using Wong Baker/FACES (age<11yr)
Time frame: 15 minutes
Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.
Change in Pain Score Using a Numeric Rating Scale (age>11yr)
Time frame: 15 minutes
Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. For patients 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.
4 secondary outcomes
Additional Opiate Medication
Time frame: Duration of ED visit, an average of 5 hrs
Patient Satisfaction
Time frame: At patient disposition, an average of 5 hrs
Rate of Admission
Time frame: Duration of ED visit, an average of 5 hrs
Rate of Return Visit
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Poor recruitment secondary to COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal ketamine in people with Sickle Cell Disease and Vaso-Occlusive Pain Episode in Sickle Cell Disease, run by Abigail Nixon at 2 sites 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?
The sponsor lists 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment secondary to COVID). 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?
Change in Pain Score Using Wong Baker/FACES (age<11yr) (time frame: 30 minutes). The study lists 6 primary outcomes in all. 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 18 Nov 2024.