LacerationPhase 2NCT03053947
Pain Free Laceration Repairs Using Intra-nasal Ketamine
A Phase 2 study testing Intranasal Ketamine in people with Laceration, run by Evelyne D.Trottier at 2 sites in Canada.
Trial summary
Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Laceration
- What is being tested?
- Intranasal Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Feb 2017to 27 Nov 2019
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 to 12 years;
- Weight between 10 and 30 kg
- Any laceration requiring sutures repair;
- Need for procedural sedation according to the emergency physician assessment for the suture repair
Who cannot join
- American Society of Anesthesiologists (ASA) physical status class III and more;
- Previous administration of IV, IN or oral analgesics or opioid other than acetaminophen and ibuprofen;
- Allergy or previous adverse reaction to ketamine;
- Aberrant nasal anatomy or nasal trauma;
- Presence of multiple trauma or eye rupture suspicion
- Head injury with loss of consciousness, decreased Glasgow Coma Scale (GCS) or intracranial bleeding;
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- Cognitive impairment;
- Known glaucoma;
- Pregnancy
- Language barrier
- Known schizophrenia or psychotic event;
- Uncontrolled hypertension;
- Airway instability (tracheal surgery, tracheal stenosis, tracheomalacia, and laryngomalacia)
- Active pulmonary infections (including upper respiratory infections)
- Known or suspected cardiac disease
- Known or suspected kidney disease
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Justine's Hospital
Montreal, Quebec, H3T 1C5
Sickkids
Toronto, Ontario, M5G 1X8
About this study
Official title: Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial
Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED.
There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.
- Conditions
- Laceration
- Being tested
- Intranasal Ketamine
- Keywords
- Intranasal Ketamine, Pain Management
- Medical subject headings
- Lacerations, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal KetamineDrug
Administration of intranasal ketamine at a dose from 3 to 9 mg/kg for safe and effective procedural sedation for laceration repair in the ED for children aged 1 to 12 year-old.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine IN | Other | All participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once. Receives: Drug: Intranasal Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.
Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair
Measured: 18 months
DosINK 2- Evaluation of the dose determined in DosINK 1 of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.
Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients
Measured: 18 months
Secondary outcomes (5)
Pain before, during and after the procedure assessed with the Faces pain scale Revised for children older than 4 year-old and with the Face Legs Activity Cry Consolability (FLACC) score for children younger than 4 year-old.
Measured: 18 months
Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.
Measured: 18 months
Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).
Measured: 18 months
Parents, patients and provider satisfaction with sedation as assessed by Likert scale.
Measured: 18 months
Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start16 Feb 2017
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelyne D.Trottier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Evelyne D.Trottier, St. Justine's Hospital
- Investigators
- Evelyne D Trottier, MD, FRCPC, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053947
- Sponsor's protocol ID
- 2017-1149
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2016
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rached-d'Astous S, Finkelstein Y, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial. Am J Emerg Med. 2023 May;67:10-16. doi: 10.1016/j.ajem.2023.01.046. Epub 2023 Jan 30.
PubMed 36774905Rached-d'Astous S, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Laceration repair using intranasal ketamine: a phase 2 dose escalation clinical trial. CJEM. 2022 Apr;24(3):347-348. doi: 10.1007/s43678-021-00235-3. Epub 2021 Dec 20. No abstract available.
PubMed 34928491
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Free Laceration Repairs Using Intra-nasal Ketamine: A Dose Escalation Clinical Trial
- ClinicalTrials.gov ID
- NCT03053947
- Acronym / sponsor ID
- 2017-1149
- Conditions
- Laceration
- Keywords
- Intranasal Ketamine, Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Evelyne D.TrottierUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 15 Feb 2017 (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.
Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED.
There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine IN | Other | Drug: Intranasal KetamineAll participants will receive intranasal Ketamine between 3mg/kg up to 9 mg/kg, once. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1 to 12 years;
- Weight between 10 and 30 kg
- Any laceration requiring sutures repair;
- Need for procedural sedation according to the emergency physician assessment for the suture repair
Key exclusion criteria (16 listed)
- American Society of Anesthesiologists (ASA) physical status class III and more;
- Previous administration of IV, IN or oral analgesics or opioid other than acetaminophen and ibuprofen;
- Allergy or previous adverse reaction to ketamine;
- Aberrant nasal anatomy or nasal trauma;
- Presence of multiple trauma or eye rupture suspicion
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 KetamineAdministration of intranasal ketamine at a dose from 3 to 9 mg/kg for safe and effective procedural sedation for laceration repair in the ED for children aged 1 to 12 year-old. | Drug | Ketamine IN |
Primary outcome
DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.
Time frame: 18 months
Dose finding : determine the optimal dose of IN ketamine between a range of 3 and 9 mg/kg for laceration suture repair
DosINK 2- Evaluation of the dose determined in DosINK 1 of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair.
Time frame: 18 months
Dose evaluation: Evaluate the dose determined in DosINK 1 in 30 patients
5 secondary outcomes
Pain before, during and after the procedure assessed with the Faces pain scale Revised for children older than 4 year-old and with the Face Legs Activity Cry Consolability (FLACC) score for children younger than 4 year-old.
Time frame: 18 months
Anxiety before, during and after the procedure assessed with the Procedure behavioural rating revised scale.
Time frame: 18 months
Sedation level during the procedure and time to return to baseline using the University of Michigan sedation scale (UMSS).
Time frame: 18 months
Parents, patients and provider satisfaction with sedation as assessed by Likert scale.
Time frame: 18 months
Sides effects and adverse events as assessed by the PERC/PECARN consensus criteria for procedural sedation in children.
Time frame: 18 months
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 16 Dec 2019.
- Derived from this study: PubMed 36774905Rached-d'Astous S, Finkelstein Y, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial. Am J Emerg Med. 2023 May;67:10-16. doi: 10.1016/j.ajem.2023.01.046. Epub 2023 Jan 30.
- Derived from this study: PubMed 34928491Rached-d'Astous S, Bailey B, Marquis C, Lebel D, Desjardins MP, Trottier ED. Laceration repair using intranasal ketamine: a phase 2 dose escalation clinical trial. CJEM. 2022 Apr;24(3):347-348. doi: 10.1007/s43678-021-00235-3. Epub 2021 Dec 20. No abstract available.
- 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.
Evelyne D Trottier, MD, FRCPC principal investigator
St. Justine's Hospital
2 sites 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 Evelyne D.Trottier at 2 sites in Canada.
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 16 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 16 Dec 2019. 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 Canada. 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?
DosINK 1-Optimal dose of intranasal ketamine for adequate procedural sedation as assessed by the PERC/PECARN consensus criteria for procedural sedation in children during their laceration repair. (time frame: 18 months). 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?
On the ClinicalTrials.gov record for NCT03053947, which also lists 2 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 16 Dec 2019.