LacerationPhase 2NCT00451724
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
A Phase 2 study testing Intranasal ketamine in people with Laceration, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Laceration
- What is being tested?
- Intranasal ketamine
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2010
- Phase
- Phase 2
- 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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 1 to 7 years old
- Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours.
- Physician feels that intravenous sedation is required to perform the laceration repair
Who cannot join
- Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure
- Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV
- Known diagnoses of hyperthyroidism or porphyria
- Glaucoma or penetrating eye injury
- Hypertension
- Any contraindication, including drug allergy, to study medications
- Severe trauma with other injuries requiring operative intervention
- Abnormal neurological exam in a previously normal child
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital
Providence, Rhode Island, 02903
About this study
The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.
Read the detailed description
Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.
- Conditions
- Laceration
- Being tested
- Intranasal ketamine
- Keywords
- Prospective, Randomized, Double blinded, Sedation, Ketamine, Intranasal
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal ketamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of sedation (OSBDR)
Measured: 30 minutes
Time to onset of sedation (Ramsay 6-point Sedation Scale)
Measured: 30 minutes
Secondary outcomes (7)
Duration of sedation
Measured: Up to 1 hour
Primary caregiver satisfaction
Measured: 24 hours
Physician satisfaction
Measured: Duration of procedure
Ketamine bioavailability
Measured: 1 hour
Abnormalities in cardiopulmonary function
Measured: Until time of discharge
Administration of supplemental sedative medication
Measured: During time required for procedure
Prolonged sedation (i.e. > 1 hour)
Measured: Until time of discharge from emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMay 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- James G Linakis, PhD, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451724
- Sponsor's protocol ID
- 0014-07
- Status last verified
- Jul 2010
- First submitted
- 21 Mar 2007
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair
- ClinicalTrials.gov ID
- NCT00451724
- Acronym / sponsor ID
- 0014-07
- Conditions
- Laceration
- Keywords
- Prospective, Randomized, Double blinded, Sedation, Ketamine, Intranasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Mar 2007 (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 compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.
Detailed description
Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 1 to 7 years old
- Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours.
- Physician feels that intravenous sedation is required to perform the laceration repair
Key exclusion criteria (8 listed)
- Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure
- Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV
- Known diagnoses of hyperthyroidism or porphyria
- Glaucoma or penetrating eye injury
- Hypertension
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 ketamine | Drug | – |
Primary outcome
Efficacy of sedation (OSBDR)
Time frame: 30 minutes
Time to onset of sedation (Ramsay 6-point Sedation Scale)
Time frame: 30 minutes
7 secondary outcomes
Duration of sedation
Time frame: Up to 1 hour
Primary caregiver satisfaction
Time frame: 24 hours
Physician satisfaction
Time frame: Duration of procedure
Ketamine bioavailability
Time frame: 1 hour
Abnormalities in cardiopulmonary function
Time frame: Until time of discharge
Administration of supplemental sedative medication
Time frame: During time required for procedure
Prolonged sedation (i.e. > 1 hour)
Time frame: Until time of discharge from emergency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
Related trials for Laceration
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Recruiting
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
Alzheimer Disease
Active, not recruiting
Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair
Supraspinatus Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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.
James G Linakis, PhD, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal ketamine in people with Laceration, run by Rhode Island Hospital at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of sedation (OSBDR) (time frame: 30 minutes). The study lists 2 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 22 Jul 2010.