EndoscopyPhase 4NCT00636428
Clinical Trial of Oral Midazolam in Pediatric Endoscopy
A Phase 4 study testing Midazolam in people with Endoscopy, run by Tabriz University at 1 site in Iran.
Trial summary
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Endoscopy
- What is being tested?
- Midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Mar 2007to Mar 2008
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All of patients scheduled for endoscopy participated in the study.
Who cannot join
- Children younger than 3 years;
- Children with significant neurological disability;
- Children with a history of allergies to benzodiazepines, or to their components;
- Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;
- Children with respiratory distress
- Age under 1 mo and bigger than 17y
- History of erythromycin used in 4 week ago
Trial locations and contacts
1 site in 1 country.
Iran1 site
Liver &Gastrointestinal Research center of tabriz medical university
Tabriz, East Azarbijan, 51664
About this study
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
Read the detailed description
Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation.
Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral midazolam Receives: Drug: Midazolam |
| 2 | Active comparator | IV Midazolam Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy and safety of endoscopy in children with used midazolam
Secondary outcomes (2)
The level of sedation
patient complications, ease of performing the procedure, time of preparation, time for recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- mandana Rafeey, Dr, Study chair, liver &Gastrointestinal Research center of tabriz medical universityMandana Rafeey, Dr, Study chair, tabriz medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636428
- Sponsor's protocol ID
- 85-24
- Status last verified
- Apr 2008
- First submitted
- 7 Mar 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Oral Midazolam in Pediatric Endoscopy
- ClinicalTrials.gov ID
- NCT00636428
- Acronym / sponsor ID
- 85-24
- Conditions
- Endoscopy
- Keywords
- endoscopy, Midazolam, pediatric, sedation, comfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Mar 2008 (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.
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.
Detailed description
Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation.
Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MidazolamOral midazolam |
| 2 | Active comparator | Drug: MidazolamIV Midazolam |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All of patients scheduled for endoscopy participated in the study.
Key exclusion criteria (7 listed)
- Children younger than 3 years;
- Children with significant neurological disability;
- Children with a history of allergies to benzodiazepines, or to their components;
- Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation;
- Children with respiratory distress
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 |
|---|---|---|
| Midazolamoral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup. | Drug | 1, 2 |
Primary outcome
efficacy and safety of endoscopy in children with used midazolam
2 secondary outcomes
The level of sedation
patient complications, ease of performing the procedure, time of preparation, time for recovery
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 11 Apr 2008.
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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.
mandana Rafeey, Dr study chair
liver &Gastrointestinal Research center of tabriz medical university
Mandana Rafeey, Dr study chair
tabriz medical university
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 in people with Endoscopy, run by Tabriz University at 1 site in Iran.
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 7 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 11 Apr 2008. 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 Iran. 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?
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?
efficacy and safety of endoscopy in children with used midazolam. 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 11 Apr 2008.