LacertaionsPhase 4NCT01470157
A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
A Phase 4 study testing Ketamine and Normal Saline in people with Lacertaions, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background: 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
- Lacertaions
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jul 2012
- 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
- Age: 1 years - 10 years
- 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
- 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
Pediatric Emergency Department
Assaf Harofeh, Zerifin, 70300
Shiri Barkan, MD, 972 544385404, shiri_barkan@yahoo.com
Shiri Barkan, MD
About this study
Official title: A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Background: 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 a few studies oral ketamine has been used successfully for procedural sedation as well. The efficacy of using a combination of oral midazolam and oral ketamine for procedural sedation has been studied only for invasive procedures in children with malignancies. No randomized controedll studies were performed using this sedative combination in children requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to oral midazolam for procedural sedation in children requiring laceration repair compares to oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study. Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral ketamine group. Both groups will be given the same volume of medications. Midazolam will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given. Patient monitoring will be conducted according to the American Academy of Pediatrics (APP) and the Israeli health ministry guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Main outcome measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive statistics will be used to describe the study population. Data will be analyzed using t- tests for continuous data and Fisher exact test for categorical data.
Key words: sedation, children, ketamine, midazolam, emergency department.
- Conditions
- Lacertaions
- Being tested
- Ketamine, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
5mg/kg as oral suspension
Normal SalineDrug
Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Oral Ketamine in addition to oral midazolam Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Normal saline (placebo) in addition to oral midazolam Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score: Visual analog score (VAS)- by parent
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 hours
Secondary outcomes (1)
Pain score: Visual analog score (VAS)- by a physician
Measured: while in the ED for about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LacertaionsStudies 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
- Principal investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470157
- Sponsor's protocol ID
- 22/11
- Status last verified
- Nov 2011
- First submitted
- 19 Sep 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Barkan S, Breitbart R, Brenner-Zada G, Feldon M, Assa A, Toledano M, Berkovitch S, Shavit I, Kozer E. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J. 2014 Aug;31(8):649-53. doi: 10.1136/emermed-2012-202189. Epub 2013 May 18.
PubMed 23686730
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
- ClinicalTrials.gov ID
- NCT01470157
- Acronym / sponsor ID
- 22/11
- Conditions
- Lacertaions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 11 Nov 2011 (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.
Background: 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 a few studies oral ketamine has been used successfully for procedural sedation as well. The efficacy of using a combination of oral midazolam and oral ketamine for procedural sedation has been studied only for invasive procedures in children with malignancies. No randomized controedll studies were performed using this sedative combination in children requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to oral midazolam for procedural sedation in children requiring laceration repair compares to oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study. Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral ketamine group. Both groups will be given the same volume of medications. Midazolam will be given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given. Patient monitoring will be conducted according to the American Academy of Pediatrics (APP) and the Israeli health ministry guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Main outcome measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive statistics will be used to describe the study population. Data will be analyzed using t- tests for continuous data and Fisher exact test for categorical data.
Key words: sedation, children, ketamine, midazolam, emergency department.
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: KetamineOral Ketamine in addition to oral midazolam |
| Placebo | Placebo comparator | Drug: Normal SalineNormal saline (placebo) in addition to oral midazolam |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 1 years - 10 years
- 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 |
|---|---|---|
| Ketamine5mg/kg as oral suspension | Drug | Ketamine |
| Normal SalineNormal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension | Drug | Placebo |
Primary outcome
Pain score: Visual analog score (VAS)- by parent
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 hours
1 secondary outcome
Pain score: Visual analog score (VAS)- by a physician
Time frame: while in the ED for about 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
- Derived from this study: PubMed 23686730Barkan S, Breitbart R, Brenner-Zada G, Feldon M, Assa A, Toledano M, Berkovitch S, Shavit I, Kozer E. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J. 2014 Aug;31(8):649-53. doi: 10.1136/emermed-2012-202189. Epub 2013 May 18.
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 Ketamine and Normal Saline in people with Lacertaions, 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 2 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 11 Nov 2011. 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. Some participants in this study may receive a placebo. 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 Shiri Barkan, MD (972 544385404, shiri_barkan@yahoo.com), 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 parent (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 hours). 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 NCT01470157, which also lists 1 linked publication.
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 11 Nov 2011.