Remimazolam for ALL, Pediatric

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh, Pittsburgh, PA
ALL, Pediatric
Remimazolam - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Remimazolam will improve 1 primary outcome and 14 secondary outcomes in patients with ALL, Pediatric. Measurement will happen over the course of 2 hours.

2 hours
Adequacy of sedation
Percentage of time within target range of sedation
Procedure success excluding cases where the procedure could not be completed for non sedative reasons
Safety: emergence of delirium
Safety: need for reversal
Safety: need for ventilation
Signs of re-sedation
Success of the procedure
Target depth of sedation achieved
Target range of sedation achieved during 80% of procedure duration
Time to fully alert
Time to ready for discharge
Time to start of procedure
3.5 hours
PK: assessment of plasma concentration-time relationship
4 days
Safety: AEs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Midazolam
Hypotension
62%
Hypertension
18%
Bradycardia
16%
Tachycardia
13%
Diastolic Hypertension
9%
Diastolic Hypotension
9%
Systolic hypertension
6%
Nausea
2%
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02290873) in the Midazolam ARM group. Side effects include: Hypotension with 62%, Hypertension with 18%, Bradycardia with 16%, Tachycardia with 13%, Diastolic Hypertension with 9%.

Trial Design

1 Treatment Group

All Patients
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. Remimazolam is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

All Patients
Drug
All paediatric patients undergoing diagnostic and/or therapeutic procedures
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remimazolam
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3.5 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3.5 hours for reporting.

Closest Location

University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
In European sites: Paediatric male or female patients, aged full term birth to <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial.
Signed informed consent form and/or assent and willingness of patient and parent(s) to participate in the trial.
In US sites: Paediatric male or female patients, aged ≥3 and <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial.
Maximum planned duration of procedure: 2 hours
ASA Physical Status I-III
Planned spontaneous breathing during sedation
A female who is of child bearing potential (i.e. after menarche) and sexually active must use a highly effective method of birth control during the trial period (from the time of consent until all specified observations are completed)
Negative pregnancy test at screening and on treatment day -

Patient Q&A Section

What causes all, pediatric?

"All and pediatric, in children and adolescents, are not associated with any single factor, but a multi-cascading process composed of genetic vulnerability, environmental factors, and psychological factors are associated with the disease. Moreover, children and adolescents with all have a more severe form of the disease than adults." - Anonymous Online Contributor

Unverified Answer

What are common treatments for all, pediatric?

"There is ample evidence for the effective use of medications in treating all forms of depression. Clinicians should be aware of the evidence, given the limitations of medications and the growing use of newer agents such as serotonin-norepinephrine reuptake inhibitors. In addition to the limitations of medications, many patients with depression also do not respond to medications. Therefore, the question arises of whether alternative therapies could play an important role in depression treatment." - Anonymous Online Contributor

Unverified Answer

What is all, pediatric?

"Given the growing numbers of pediatric and adolescent patients with cancer, there is a need for a strong medical education to support the management of children and young people through survivorship." - Anonymous Online Contributor

Unverified Answer

How many people get all, pediatric a year in the United States?

"A significant number of infants (approximately 7.9 million a year) receive one or more vaccines during their first year of life and are at risk for serious complications. These are associated with many healthcare resources (medical care, hospital admissions, ICUs, and inpatient care). The potential for a large number of serious infections may reduce the utility and cost-effectiveness of vaccines during infancy." - Anonymous Online Contributor

Unverified Answer

Is remimazolam safe for people?

"Children are particularly vulnerable to sedative effects of benzodiazepines and this drug has been known to occur in a significant proportion of patients in pediatric wards. Thus children are a particularly exposed group of persons after taking a dose of remimazolam and it is advisable to restrict use of this medication to children." - Anonymous Online Contributor

Unverified Answer

Can all, pediatric be cured?

"Each cancer needs a particular treatment approach, and individual results vary considerably. However, when the specific disease and needs are taken into account, some cancer patients can and do be cured. To the extent possible, all patients would benefit from proven approaches. The cure rate needs to increase and the treatment approach improved." - Anonymous Online Contributor

Unverified Answer

What are the signs of all, pediatric?

"The signs and symptoms of pneumonia in children and adolescents are similar to those seen in adults. The most common presenting symptoms in children are respiratory symptoms, such as fever and cough. Fever is often more severe and is typically accompanied by other symptoms of respiratory illness, such as increased respiratory rate, decreased breathing room, altered breathing sounds, an increased rate of breathing and the presence of wheezing. Children with pneumonia often develop chest pain in addition to the respiratory symptoms. A child with pleuritic symptoms or pneumonia with an abdominal distention should be evaluated with suspicion for the cause of these symptoms. Children with pleuritic symptoms should be evaluated by a doctor for the presence of pneumonia since pleuritic pain can be caused by the inflammatory response to pneumonia." - Anonymous Online Contributor

Unverified Answer

How serious can all, pediatric be?

"Severe gastrointestinal or pancreatic disease in children may require exploratory laparotomy to control gastrointestinal symptoms to facilitate an endoscopy and biopsy. Laparotomy is associated with an increased risk of serious complications, although the risk is minimal when performed by a well-trained surgeon. However, the impact of laparotomy on hospital charges, time off from school, and quality of life is difficult to evaluate. The most reliable predictor of serious complication is a high BMI in the absence of severe comorbidities in children." - Anonymous Online Contributor

Unverified Answer

Has remimazolam proven to be more effective than a placebo?

"No significant difference between the effect of remimazolam and a placebo was found. Remimazolam was not more effective than a placebo in lowering anxiety and insomnia in pediatric patients. However further studies examining individual patient needs are essential to better understand the need for benzodiazepine treatment." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in remimazolam for therapeutic use?

"Oral remimazolam for the treatment of anxiety and insomnia is effective and well tolerated and offers a range of tolerability levels that may be tailored to individual patient preferences. The extended release formulation in pediatric patients has been well tolerated with an optimal pharmacokinetic profile. Both of these observations have recently been confirmed by a placebo-controlled clinical trial of remimazolam in adolescents with the diagnostic test: Sleep Disorder and Associated Traumatic Stress in Children (SOLIDS). Future studies aiming to refine and extend these observations regarding the expanded release formulation as a treatment of anxiety and insomnia in children are currently being carried out by SOLIDS." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for all, pediatric?

"Current PPI trials are most prevalent in adults. It is essential to educate the public, especially children and physicians, to assure that all ages are evaluated in phase 2- or phase 3-standard clinical trials for PPI treatments." - Anonymous Online Contributor

Unverified Answer

What is the latest research for all, pediatric?

"While many of the studies have been conducted before the publication of the latest Cochrane review, there is a large amount of research still needed, especially since clinicians are beginning to make more accurate diagnoses. A study in New Zealand for pediatric anxiety disorder found that [all, pediatric anxiety disorder symptoms occurred in 25% of children with anxiety, compared with 17.4% for all anxiety disorders] and that [in the United Kingdom, pediatric anxiety disorder symptoms occurred in 11% of children with anxiety, compared with 9.4% for all anxiety disorders] [Cameron, D., et al. (2005) Clin Pediatr Psychol. 17, 826-834 ((online)]." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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