AnxietyNCT00675909
Improving Sedation of Children Undergoing Procedures in the Emergency Department
A study testing Aerosolized Intranasal midazolam, Aerosolized Buccal Midazolam and Oral midazolam in people with Anxiety, run by Seattle Children's Hospital.
Trial summary
Lacerations (deep cuts) are a frequent cause of visits to emergency departments and laceration repair is one of the most common procedures performed in that setting. Children are often anxious when they visit the emergency department, and visits where they anticipate needing painful procedures can be particularly… Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Aerosolized Intranasal midazolam, Aerosolized Buccal Midazolam and Oral midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2010
- Phase
- Interventional
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Laceration in need of repair with sutures, with no other major injuries
- Age >=6 months and < 7 years
- No meal within the last 2 hours
Who cannot join
- Closed head injury associated with loss of consciousness
- Abnormal neurologic exam, relative to baseline status
- Significant developmental delay or baseline neurologic deficit
- Severe trauma with suspected internal injuries
- Acute or chronic respiratory condition
- Acute or chronic renal, cardiac or hepatic abnormalities
Show all 9Show fewer
- Allergy to benzodiazepines or previous reaction to benzodiazepines
- Taking erythromycin containing antibiotics
- Nasal and intraoral lacerations
About this study
Official title: Improving Sedation of Children Undergoing Procedures in the Emergency Department: Evaluation of Different Dosages and Routes of Administration of the Sedative Midazolam
Lacerations (deep cuts) are a frequent cause of visits to emergency departments and laceration repair is one of the most common procedures performed in that setting. Children are often anxious when they visit the emergency department, and visits where they anticipate needing painful procedures can be particularly stressful. Though we can manage the pain associated with many minor procedures, we are frequently unable to adequately support the child and treat their problem if we don't manage their anxiety as well. Methods of calming that do not require medication (e.g. distraction, parental support) can help, but many patients still require sedative medications.
The goal of sedation in the pediatric emergency department is to relieve the child's anxiety while minimizing the risk of adverse events. Unfortunately, when sedative medications are used in doses that do not slow breathing, they often fail to manage the child's anxiety adequately. In addition, many sedative agents require the placement of an intravenous line, which is itself a painful procedure that can create, rather than relieve, anxiety.
Read more
Currently, there is no ideal sedative agent that is safe, effective, and easy to administer. Oral midazolam is one of the most commonly used sedative medications for laceration repair in children. In a dose of 0.5mg/kg it has been shown to be safe. Unfortunately, it provides adequate sedation in only about two thirds of patients and has a delayed onset of up to 20 minutes. The remaining children must either endure the procedure in an agitated state or suffer placement of an intravenous line to administer additional sedative medications.
We aim to find a method of providing sedation for laceration repair that has a higher success rate than oral midazolam as currently prescribed without increasing the risk of complications. We would like to evaluate new methods for administering midazolam using alternate routes and dosages. Previous studies have looked at the use of midazolam absorbed directly by mucous membranes such as inside the nose (intranasal) and inside the mouth (buccal). The use of intranasal midazolam has had some success especially given its rapid onset of action (about 5 minutes), but has been limited by the irritant effects of the drug. When placed in the mouth, many children swallow the drug or spit it out rather than allowing it to be absorbed by the mucous membrane. There has been some improved success when the drug was placed under the tongue, but this is typically difficult for young children. However, a new device called an "atomizer" has been developed that allows for improved intranasal and buccal administration. The "atomizer" has a small adapter placed on the end of a syringe, which spreads the medication out in a fine mist over a wide area. It can be sprayed in the mouth inside the cheek (buccal), avoiding the need to keep the medication under the tongue. While some pediatric institutions have already started giving midazolam with the atomizer, and are reporting anecdotal success with these methods, its safety and effectiveness have not been rigorously studied.
We propose to compare three approaches to sedation: commonly used doses of oral midazolam, atomized intranasal midazolam and atomized intraoral midazolam. Children under the age of 7 requiring sedation for wound repair will be eligible for enrollment. After informed consent, children will be randomized to one of the three methods described above. Their level of sedation will be determined using two scores validated for use in children (the sedation score and the modified CHEOPS score). Physician, nurse and parent impressions of sedation will also be compared.
By comparing our current approach to these new methods, we will be able to determine which method is best. If we can identify a method for administering the sedative drug midazolam that is safe, well tolerated, and more effective, we will have made a valuable and important contribution to the care of injured children in the emergency department.
Read the detailed description
The goal of this study is to improve sedation of children undergoing laceration repair in the emergency department. Currently, children who require sedation for laceration repair most often receive short acting benzodiazepines (i.e.,midazolam) orally (by mouth). Studies on the effectiveness of oral midazolam for minor procedures cite a 50-75% success rate. Oral midazolam has variable effectiveness and onset of action, and due to first pass hepatic metabolism, oral midazolam has a bioavailability of only 27% in children (Blumer 1998). Given the low success rate of oral midazolam, administration via mucous membranes has also been attempted. When administered intranasally or buccally, midazolam has a much higher bioavailability (Walberg 1991) and more rapid onset of action. Unfortunately, when given by these routes in previous studies, it was dripped into the nose or placed under the tongue. This leads to either swallowing the liquid drug, or expelling it, leading again to suboptimal bioavailability. Moreover, intranasal midazolam is irritating to the nasal mucosa and has therefore not always been well tolerated. When given to cooperative adults, midazolam dripped onto mucosal surfaces can have a bioavailability of approximately 75% (Schwagmeier 1998).
It has been hypothesized that better distribution of midazolam on mucosal surfaces would improve the reliability and effectiveness of this route of administration. A device called an atomizer has been developed for just this purpose (Wolfe Tory Medical, Inc., Salt Lake City, UT). The atomizer is an attachment on the end of a small syringe that causes the medication to be propelled over a larger surface area in a spray (see Figure below). This allows a greater percentage of the medication to be absorbed via the mucosal surface with a direct route to the blood stream leading to faster and more reliable onset of action, while avoiding the problem of hepatic metabolism that occurs with enterally absorbed midazolam.
We propose a study to determine if changes in the mode of administration and dosing of midazolam can provide improved sedation for children undergoing anxiety-producing procedures, without adversely effecting safety, length of stay, or patient/family and staff satisfaction.
To study this, we propose a randomized clinical trial to compare three methods of administering midazolam for sedation: oral midazolam 0.5 mg per kg, buccal midazolam 0.3 mg per kg and intranasal midazolam 0.3 mg per kg. The subject population will be children under the age of 7 who require sedation for laceration repair in the Emergency Department of Children's Hospital and Regional Medical Center. Patients will be excluded if they have: closed head injury with loss of consciousness, abnormal neurologic exam relative to baseline status, severe developmental delay or baseline neurologic deficits, severe trauma with suspected internal injuries, acute or chronic respiratory conditions, or renal, cardiac or hepatic abnormalities.
Variables of interest will include level of sedation prior to and during the procedure (using an activity scale and a modified CHEOPS scale) (McGrath 1985), time to adequate sedation, procedure length, length of ED stay, parental, MD, and RN satisfaction using a Likert scale, and complications such as respiratory depression and vomiting as well as measures needs to ameliorate those complications. For adequate power, we anticipate enrolling 180 patients (60 in each treatment group) during the 24-month duration of the study.
- Conditions
- Anxiety
- Being tested
- Aerosolized Intranasal midazolam, Aerosolized Buccal Midazolam, Oral midazolam
- Keywords
- Sedation, Anxiety, Minor procedures, Emergency Department
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized Intranasal midazolamDrug
Also called Versed
Midazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg.
Aerosolized Buccal MidazolamDrug
Also called Versed
0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth.
Oral midazolamDrug
Also called Versed
oral midazolam 0.5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Oral Midazolam | Active comparator | Oral midazolam 0.5mg/kg Receives: Drug: Oral midazolam |
| Aerosolized intranasal midazolam | Experimental | Intranasal midazolam 0.3mg/kg Receives: Drug: Aerosolized Intranasal midazolam |
| Aerosolized buccal midazolam | Experimental | Buccal midazolam 0.3mg/kg Receives: Drug: Aerosolized Buccal Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).
Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation.
Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3).
Measured: Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).
Secondary outcomes (4)
Time From Study Drug Administration to Start of Procedure
Measured: Time from study drug administration to start of procedure up to 68 minutes
Duration of Procedure
Measured: Duration of procedure up to 40 minutes
Physician Rating of Sedation
Range is 0-10. Higher is associated with physician impression that sedation is better.
Measured: Physician was asked after the procedure was done about their impression of sedation.
Nurse Rating of Sedation
Range is 0-10. Higher is associated with nurse impression that sedation is better.
Measured: After the procedure nurse was asked about their impression of the level of sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionJan 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Klein, Seattle Children's Hospital
- Investigators
- Eileen J Klein, MD, MPH, Principal investigator, Associate Professor, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675909
- Sponsor's protocol ID
- 2005-0260A
- Status last verified
- Nov 2018
- First submitted
- 8 May 2008
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Klein EJ, Brown JC, Kobayashi A, Osincup D, Seidel K. A randomized clinical trial comparing oral, aerosolized intranasal, and aerosolized buccal midazolam. Ann Emerg Med. 2011 Oct;58(4):323-9. doi: 10.1016/j.annemergmed.2011.05.016.
PubMed 21689865
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sedation of Children Undergoing Procedures in the Emergency Department: Evaluation of Different Dosages and Routes of Administration of the Sedative Midazolam
- ClinicalTrials.gov ID
- NCT00675909
- Acronym / sponsor ID
- 2005-0260A
- Conditions
- Anxiety
- Keywords
- Sedation, Anxiety, Minor procedures, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Posted 7 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lacerations (deep cuts) are a frequent cause of visits to emergency departments and laceration repair is one of the most common procedures performed in that setting. Children are often anxious when they visit the emergency department, and visits where they anticipate needing painful procedures can be particularly stressful. Though we can manage the pain associated with many minor procedures, we are frequently unable to adequately support the child and treat their problem if we don't manage their anxiety as well. Methods of calming that do not require medication (e.g. distraction, parental support) can help, but many patients still require sedative medications.
The goal of sedation in the pediatric emergency department is to relieve the child's anxiety while minimizing the risk of adverse events. Unfortunately, when sedative medications are used in doses that do not slow breathing, they often fail to manage the child's anxiety adequately. In addition, many sedative agents require the placement of an intravenous line, which is itself a painful procedure that can create, rather than relieve, anxiety.
Currently, there is no ideal sedative agent that is safe, effective, and easy to administer. Oral midazolam is one of the most commonly used sedative medications for laceration repair in children. In a dose of 0.5mg/kg it has been shown to be safe. Unfortunately, it provides adequate sedation in only about two thirds of patients and has a delayed onset of up to 20 minutes. The remaining children must either endure the procedure in an agitated state or suffer placement of an intravenous line to administer additional sedative medications.
We aim to find a method of providing sedation for laceration repair that has a higher success rate than oral midazolam as currently prescribed without increasing the risk of complications. We would like to evaluate new methods for administering midazolam using alternate routes and dosages. Previous studies have looked at the use of midazolam absorbed directly by mucous membranes such as inside the nose (intranasal) and inside the mouth (buccal). The use of intranasal midazolam has had some success especially given its rapid onset of action (about 5 minutes), but has been limited by the irritant effects of the drug. When placed in the mouth, many children swallow the drug or spit it out rather than allowing it to be absorbed by the mucous membrane. There has been some improved success when the drug was placed under the tongue, but this is typically difficult for young children. However, a new device called an "atomizer" has been developed that allows for improved intranasal and buccal administration. The "atomizer" has a small adapter placed on the end of a syringe, which spreads the medication out in a fine mist over a wide area. It can be sprayed in the mouth inside the cheek (buccal), avoiding the need to keep the medication under the tongue. While some pediatric institutions have already started giving midazolam with the atomizer, and are reporting anecdotal success with these methods, its safety and effectiveness have not been rigorously studied.
We propose to compare three approaches to sedation: commonly used doses of oral midazolam, atomized intranasal midazolam and atomized intraoral midazolam. Children under the age of 7 requiring sedation for wound repair will be eligible for enrollment. After informed consent, children will be randomized to one of the three methods described above. Their level of sedation will be determined using two scores validated for use in children (the sedation score and the modified CHEOPS score). Physician, nurse and parent impressions of sedation will also be compared.
By comparing our current approach to these new methods, we will be able to determine which method is best. If we can identify a method for administering the sedative drug midazolam that is safe, well tolerated, and more effective, we will have made a valuable and important contribution to the care of injured children in the emergency department.
Detailed description
The goal of this study is to improve sedation of children undergoing laceration repair in the emergency department. Currently, children who require sedation for laceration repair most often receive short acting benzodiazepines (i.e.,midazolam) orally (by mouth). Studies on the effectiveness of oral midazolam for minor procedures cite a 50-75% success rate. Oral midazolam has variable effectiveness and onset of action, and due to first pass hepatic metabolism, oral midazolam has a bioavailability of only 27% in children (Blumer 1998). Given the low success rate of oral midazolam, administration via mucous membranes has also been attempted. When administered intranasally or buccally, midazolam has a much higher bioavailability (Walberg 1991) and more rapid onset of action. Unfortunately, when given by these routes in previous studies, it was dripped into the nose or placed under the tongue. This leads to either swallowing the liquid drug, or expelling it, leading again to suboptimal bioavailability. Moreover, intranasal midazolam is irritating to the nasal mucosa and has therefore not always been well tolerated. When given to cooperative adults, midazolam dripped onto mucosal surfaces can have a bioavailability of approximately 75% (Schwagmeier 1998).
It has been hypothesized that better distribution of midazolam on mucosal surfaces would improve the reliability and effectiveness of this route of administration. A device called an atomizer has been developed for just this purpose (Wolfe Tory Medical, Inc., Salt Lake City, UT). The atomizer is an attachment on the end of a small syringe that causes the medication to be propelled over a larger surface area in a spray (see Figure below). This allows a greater percentage of the medication to be absorbed via the mucosal surface with a direct route to the blood stream leading to faster and more reliable onset of action, while avoiding the problem of hepatic metabolism that occurs with enterally absorbed midazolam.
We propose a study to determine if changes in the mode of administration and dosing of midazolam can provide improved sedation for children undergoing anxiety-producing procedures, without adversely effecting safety, length of stay, or patient/family and staff satisfaction.
To study this, we propose a randomized clinical trial to compare three methods of administering midazolam for sedation: oral midazolam 0.5 mg per kg, buccal midazolam 0.3 mg per kg and intranasal midazolam 0.3 mg per kg. The subject population will be children under the age of 7 who require sedation for laceration repair in the Emergency Department of Children's Hospital and Regional Medical Center. Patients will be excluded if they have: closed head injury with loss of consciousness, abnormal neurologic exam relative to baseline status, severe developmental delay or baseline neurologic deficits, severe trauma with suspected internal injuries, acute or chronic respiratory conditions, or renal, cardiac or hepatic abnormalities.
Variables of interest will include level of sedation prior to and during the procedure (using an activity scale and a modified CHEOPS scale) (McGrath 1985), time to adequate sedation, procedure length, length of ED stay, parental, MD, and RN satisfaction using a Likert scale, and complications such as respiratory depression and vomiting as well as measures needs to ameliorate those complications. For adequate power, we anticipate enrolling 180 patients (60 in each treatment group) during the 24-month duration of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Midazolam | Active comparator | Drug: Oral midazolamOral midazolam 0.5mg/kg |
| Aerosolized intranasal midazolam | Experimental | Drug: Aerosolized Intranasal midazolamIntranasal midazolam 0.3mg/kg |
| Aerosolized buccal midazolam | Experimental | Drug: Aerosolized Buccal MidazolamBuccal midazolam 0.3mg/kg |
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Laceration in need of repair with sutures, with no other major injuries
- Age >=6 months and < 7 years
- No meal within the last 2 hours
Key exclusion criteria (9 listed)
- Closed head injury associated with loss of consciousness
- Abnormal neurologic exam, relative to baseline status
- Significant developmental delay or baseline neurologic deficit
- Severe trauma with suspected internal injuries
- Acute or chronic respiratory condition
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 |
|---|---|---|
| Aerosolized Intranasal midazolamAlso: VersedMidazolam will be administered via aerosolization (using "atomizer") with half of dose in each nostril. Total dose is 0.3mg/kg. | Drug | Aerosolized intranasal midazolam |
| Aerosolized Buccal MidazolamAlso: Versed0.3mg/kg total dose administered with aerosolization device ("atomizer") sprayed onto buccal mucosa inside the cheek on both sides of mouth. | Drug | Aerosolized buccal midazolam |
| Oral midazolamAlso: Versedoral midazolam 0.5mg/kg | Drug | Oral Midazolam |
Primary outcome
Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).
Time frame: Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).
Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation. Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3).
4 secondary outcomes
Time From Study Drug Administration to Start of Procedure
Time frame: Time from study drug administration to start of procedure up to 68 minutes
Duration of Procedure
Time frame: Duration of procedure up to 40 minutes
Physician Rating of Sedation
Time frame: Physician was asked after the procedure was done about their impression of sedation.
Nurse Rating of Sedation
Time frame: After the procedure nurse was asked about their impression of the level of sedation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21689865Klein EJ, Brown JC, Kobayashi A, Osincup D, Seidel K. A randomized clinical trial comparing oral, aerosolized intranasal, and aerosolized buccal midazolam. Ann Emerg Med. 2011 Oct;58(4):323-9. doi: 10.1016/j.annemergmed.2011.05.016.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Eileen J Klein, MD, MPH principal investigator
Associate Professor, Pediatrics
Questions about this trial
What is this clinical trial studying?
A study testing Aerosolized Intranasal midazolam, Aerosolized Buccal Midazolam and Oral midazolam in people with Anxiety, run by Seattle Children's Hospital.
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 9 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2012). 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?
Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair). (time frame: Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).). 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 NCT00675909, 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 9 Nov 2018.