Laceration of SkinPhase 4NCT03528512
IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair
A Phase 4 study testing Ketamine and Midazolam and fentanyl in people with Laceration of Skin, run by Corewell Health East at 1 site in United States.
Trial summary
Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Laceration of Skin
- What is being tested?
- Ketamine and Midazolam and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 6 Feb 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.
- Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.
- Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.
Who cannot join
- Age < 6 months
- Documented allergy or adverse effect to ketamine, midazolam or fentanyl
- Epistaxis
- Partial upper airway obstruction
- Oxygen requirement via nasal cannula
- Acute mental status changes (e.g. obtunded or somnolent)
Show all 17Show fewer
- Documented increased intracranial pressure or increased ocular pressure
- Documented porphyria
- Previously involved in the study
- Parent or patient refusal
- Acutely compromised vitals (hypotension, desaturations, respiratory distress)
- Any known heart disease
- If any previous opioid use for analgesia during the visit
- Need for staples
- Scalp wounds
- General trauma requiring additional sedation
- Patients who received pain medications (acetaminophen or ibuprofen) before laceration repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Comparison of Sedation, Pain, and Care Provider Satisfaction Between the Use of Intranasal Ketamine Versus Intranasal Midazolam and Fentanyl During Laceration Repair
Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety during repair of cuts in children.
Read the detailed description
Children frequently present to pediatric emergency center (PEC) with cuts of different body parts. Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents alike. Ideally, repair of the cuts should be as painless and free from anxiety as possible. To work towards this goal, different analgesic (pain drugs) and sedative ( to calm patients down) management strategies use intravenous (into the vein), intramuscular ( into the muscle) and, more recently, intranasal (into the nostrils) routes. Unfortunately, intravenous access is hard to establish and may be painful for the child. The intramuscular route is often similarly painful. Due to the rich blood supply and large surface area of the nasal vestibule, intranasally (IN) administered medications are highly absorbed. IN approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated, making it an attractive potential alternative to commonly used intravenous and intramuscular approaches. In several small research studies, high doses of intranasal ketamine (9 mg/kg) produce adequate sedation during laceration repair with minimal side effects. A recent study compared IN ketamine, midazolam, fentanyl or combination of these drugs for pain management and urgent analgesia sedation, and demonstrated that they are effective and safe, reporting that ~60% of study participants sustained mild to moderate sedation. Unfortunately, there are not enough studies done to evaluate the sedation effect of IN ketamine for laceration repair. Small studies (Tsze and Nemeth) showed that IN ketamine is an effective alternative but no studies are done to compare combination IN midazolam and fentanyl to IN ketamine. Our null hypothesis is that there is no difference in sedation scores during laceration repair when comparing the use of IN ketamine to IN midazolam and IN fentanyl.
We will recruit a total of 30 pediatric patients (6 months - 10 y age) in a randomized double-blinded pilot study of IN ketamine alone or combined IN midazolam and IN fentanyl for laceration repair, comparing levels of pain and sedation scores using validated pediatric metrics as the primary outcomes. In addition, we will assess comparative nurse and physician satisfaction in each of these two groups. Understanding the relative effectiveness of these two approaches will help us identify a safe, effective, and easily administrable method to manage pain and anxiety, thereby, improving patient experience and outcomes during the often traumatic laceration repair procedure.
- Conditions
- Laceration of Skin
- Being tested
- Ketamine, Midazolam and fentanyl
- Keywords
- Pediatric, analgesia, pain control, sedation, intranasal ketamine, intranasal midazolam, intranasal fentanyl
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
Midazolam and fentanylDrug
Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
| Study group | Role | What they receive |
|---|---|---|
| IN ketamine | Experimental | Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Receives: Drug: Ketamine |
| IN midazolam and fentanyl | Active comparator | Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Receives: Drug: Midazolam and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation Score
The primary outcome variable is the maximum sedation score as measured by the University of Michigan Sedation Scale. This scale consists of an ordinal scale from 0 being awake and alert and 4 being unarousable. Medians will be calculated for each group.
Measured: up to 30 minutes
Proportion of Children With Maximum Sedation Score
The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)
Measured: Up to 30 minutes
Secondary outcomes (4)
Pain Scores During Laceration Repair
The effect of IN ketamine vs IN midazolam + IN fentanyl on pain scores during laceration repair using either Face, Legs, Activity, Cry, Consolability (FLACC) Scale or Faces Scale pain scale depending for patient age, each a Likert scale from 0 being no pain to 10 being worst pain, median scores for each group
Measured: Up to 30 minutes
Nurse and Physician Satisfaction
Nurse and physician satisfaction will be assessed by a survey which will be filled in the end of the sedation. Response to overall experience question score on Likert scale where 1 is poor and 5 is Excellent. Proportion of responders giving answers of 4 or 5 will be calculated.
Measured: Up to 30 minutes
Rates of Failure
Rates of failure to repair laceration due to agitation or intolerable pain with the switch to intravenous medications will be compared between two groups. Percentage failure will be reported.
Measured: Up to 30 minutes
Change in Vitals
Proportion of children who have any significant change in vitals during analgosedation (any desaturation - Oxygen saturation < 90, and hypotension per age-related norms) will be compared between the two groups.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start4 Sep 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Why it stopped: Staffing for study was eliminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laceration of SkinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret J Menoch, MD, Corewell Health East
- Investigators
- Kelly Levasseur, DO, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528512
- Sponsor's protocol ID
- 2017-363
- Status last verified
- Jul 2021
- First submitted
- 5 May 2018
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sedation, Pain, and Care Provider Satisfaction Between the Use of Intranasal Ketamine Versus Intranasal Midazolam and Fentanyl During Laceration Repair
- ClinicalTrials.gov ID
- NCT03528512
- Acronym / sponsor ID
- 2017-363
- Conditions
- Laceration of Skin
- Keywords
- Pediatric, analgesia, pain control, sedation, intranasal ketamine, intranasal midazolam, intranasal fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing for study was eliminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety during repair of cuts in children.
Detailed description
Children frequently present to pediatric emergency center (PEC) with cuts of different body parts. Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents alike. Ideally, repair of the cuts should be as painless and free from anxiety as possible. To work towards this goal, different analgesic (pain drugs) and sedative ( to calm patients down) management strategies use intravenous (into the vein), intramuscular ( into the muscle) and, more recently, intranasal (into the nostrils) routes. Unfortunately, intravenous access is hard to establish and may be painful for the child. The intramuscular route is often similarly painful. Due to the rich blood supply and large surface area of the nasal vestibule, intranasally (IN) administered medications are highly absorbed. IN approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated, making it an attractive potential alternative to commonly used intravenous and intramuscular approaches. In several small research studies, high doses of intranasal ketamine (9 mg/kg) produce adequate sedation during laceration repair with minimal side effects. A recent study compared IN ketamine, midazolam, fentanyl or combination of these drugs for pain management and urgent analgesia sedation, and demonstrated that they are effective and safe, reporting that ~60% of study participants sustained mild to moderate sedation. Unfortunately, there are not enough studies done to evaluate the sedation effect of IN ketamine for laceration repair. Small studies (Tsze and Nemeth) showed that IN ketamine is an effective alternative but no studies are done to compare combination IN midazolam and fentanyl to IN ketamine. Our null hypothesis is that there is no difference in sedation scores during laceration repair when comparing the use of IN ketamine to IN midazolam and IN fentanyl.
We will recruit a total of 30 pediatric patients (6 months - 10 y age) in a randomized double-blinded pilot study of IN ketamine alone or combined IN midazolam and IN fentanyl for laceration repair, comparing levels of pain and sedation scores using validated pediatric metrics as the primary outcomes. In addition, we will assess comparative nurse and physician satisfaction in each of these two groups. Understanding the relative effectiveness of these two approaches will help us identify a safe, effective, and easily administrable method to manage pain and anxiety, thereby, improving patient experience and outcomes during the often traumatic laceration repair procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded control trial
| Arm | Type | Receives |
|---|---|---|
| IN ketamine | Experimental | Drug: KetamineIntranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) |
| IN midazolam and fentanyl | Active comparator | Drug: Midazolam and fentanylIntranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.
- Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.
- Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.
Key exclusion criteria (17 listed)
- Age < 6 months
- Documented allergy or adverse effect to ketamine, midazolam or fentanyl
- Epistaxis
- Partial upper airway obstruction
- Oxygen requirement via nasal cannula
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 |
|---|---|---|
| KetamineIntranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) | Drug | IN ketamine |
| Midazolam and fentanylIntranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) | Drug | IN midazolam and fentanyl |
Primary outcome
Sedation Score
Time frame: up to 30 minutes
The primary outcome variable is the maximum sedation score as measured by the University of Michigan Sedation Scale. This scale consists of an ordinal scale from 0 being awake and alert and 4 being unarousable. Medians will be calculated for each group.
Proportion of Children With Maximum Sedation Score
Time frame: Up to 30 minutes
The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)
4 secondary outcomes
Pain Scores During Laceration Repair
Time frame: Up to 30 minutes
Nurse and Physician Satisfaction
Time frame: Up to 30 minutes
Rates of Failure
Time frame: Up to 30 minutes
Change in Vitals
Time frame: up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly Levasseur, DO principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Midazolam and fentanyl in people with Laceration of Skin, run by Corewell Health East 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 17 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 24 Aug 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sedation Score (time frame: up to 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 24 Aug 2021.