LacerationsPhase 4NCT01925898
A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
A Phase 4 study testing Midazolam - active comparator and Experimental Arm: Ketamine in people with Lacerations, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Lacerations
- What is being tested?
- Midazolam - active comparator and Experimental Arm: Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 4
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any child with laceration requiring sedation
Who cannot join
- Major trauma
- Closed head injury associated with loss of consciousness
- Abnormal neurologic examination in a previously normal child
- Significant developmental delay or baseline neurological deficit
- A patient with seizures
- Elevated intra-cranial pressure
Show all 15Show fewer
- Hypersensitivity to midazolam or ketamine
- Hypertension
- Hyperthyroidism or a patient receiving thyroid replacement
- alcohol intoxication or a history of alcohol abuse
- Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
- Glaucoma
- Known psychiatric disease
- American Society of Anesthesiologists (ASA) score of more than 2
- Informed consent cannot be obtained from legal guardian
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh MC
Be’er Ya‘aqov
Orit Rubinstein, MD, 972-8-9779916, oritar78@gmail.com
Orit Rubinstein, MD
About this study
Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery
Hypothesis:
Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.
- Conditions
- Lacerations
- Being tested
- Midazolam - active comparator, Experimental Arm: Ketamine
- Keywords
- Laceration, Sedation, Pediatrics
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam - active comparatorDrug
Also called Dormicum
Oral midazolam - 0.7mg/kg single dose
Experimental Arm: KetamineDrug
Also called Ketalar
Oral Ketamine 5mg/kg Single dose
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Oral ketamine Receives: Drug: Experimental Arm: Ketamine |
| Midazolam | Active comparator | Oral Midazolam Receives: Drug: Midazolam - active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score: Visual analog score (VAS)- by a parent
A parent will assess the child's pain on a Visual analog scale
Measured: During the procedure - up to 1 hour
Number of patients requiring IV sedation
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
Measured: During the procedure - up to 1 hour
Secondary outcomes (7)
UMSS - by ED physician
Measured: During the procedure - up to 1 hour
• VAS by nurse
Measured: During the procedure - up to 1 hour
Time to reach UMSS > 2
Measured: up to 1 hour
• Procedure time
Measured: During the procedure - up to 1 hour
• Time from procedure to full recovery
Measured: While in the ED - estimated time around 2 hours
The occurrence of adverse effects during the ED stay
Significant adverse effects are defined as
- Oxygen desaturation <92% or hypoventilation requiering ventilatory support
- Need for hemodynamic support
- Anaphylaxis
- Seizures
- Any adverse effects requiring patient admission
Measured: While in the ED - estimated time around 2 hours
• Patients and parents satisfaction assessed on VAS
Measured: While in the ED - estimated time around 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925898
- Sponsor's protocol ID
- 87/13
- Status last verified
- Aug 2013
- First submitted
- 17 Jul 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
- ClinicalTrials.gov ID
- NCT01925898
- Acronym / sponsor ID
- 87/13
- Conditions
- Lacerations
- Keywords
- Laceration, Sedation, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 20 Aug 2013 (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.
Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery
Hypothesis:
Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Experimental Arm: KetamineOral ketamine |
| Midazolam | Active comparator | Drug: Midazolam - active comparatorOral Midazolam |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any child with laceration requiring sedation
Key exclusion criteria (15 listed)
- Major trauma
- Closed head injury associated with loss of consciousness
- Abnormal neurologic examination in a previously normal child
- Significant developmental delay or baseline neurological deficit
- A patient with seizures
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 |
|---|---|---|
| Midazolam - active comparatorAlso: DormicumOral midazolam - 0.7mg/kg single dose | Drug | Midazolam |
| Experimental Arm: KetamineAlso: KetalarOral Ketamine 5mg/kg Single dose | Drug | Ketamine |
Primary outcome
Pain score: Visual analog score (VAS)- by a parent
Time frame: During the procedure - up to 1 hour
A parent will assess the child's pain on a Visual analog scale
Number of patients requiring IV sedation
Time frame: During the procedure - up to 1 hour
patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation
7 secondary outcomes
UMSS - by ED physician
Time frame: During the procedure - up to 1 hour
• VAS by nurse
Time frame: During the procedure - up to 1 hour
Time to reach UMSS > 2
Time frame: up to 1 hour
• Procedure time
Time frame: During the procedure - up to 1 hour
• Time from procedure to full recovery
Time frame: While in the ED - estimated time around 2 hours
The occurrence of adverse effects during the ED stay
Time frame: While in the ED - estimated time around 2 hours
• Patients and parents satisfaction assessed on VAS
Time frame: While in the ED - estimated time around 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Lacerations
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.
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 Midazolam - active comparator and Experimental Arm: Ketamine in people with Lacerations, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 15 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Kozer, MD (972-8-9779916, erank@assaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score: Visual analog score (VAS)- by a parent (time frame: During the procedure - up to 1 hour). 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 Jan 2014.