Remimazolam for Sedation in Children's Medical Procedures

Not currently recruiting at 7 trial locations

Overseen By Joanna L Walker

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Acacia Pharma Ltd

Must not be taking: Benzodiazepines

Disqualifiers: Sleep apnoea, Respiratory failure, Cardiac failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sedation drug, remimazolam, to evaluate its effectiveness for children needing to stay calm and comfortable during medical procedures. The goal is to determine if this drug can safely and effectively help children relax without requiring a breathing tube. Suitable candidates are children scheduled for a medical procedure lasting less than two hours who can breathe independently during sedation. The trial excludes children with airway issues, severe allergies to certain drugs, or those needing emergency procedures. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions 'prohibited medication' as an exclusion criterion, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that remimazolam is likely to be safe for children?

Research has shown that remimazolam is generally safe for children. One study found it keeps the heart more stable than propofol, a common sedative, potentially causing fewer heart problems. Another review suggests that remimazolam is safer and more predictable than the sedatives typically used for children.

Evidence also indicates that remimazolam can be safely combined with other sedatives like propofol or ketamine. This combination can be effective while maintaining safety during procedures. Although it appears to be a safe option, some details about its effects in certain situations are still under investigation. Overall, early findings suggest that remimazolam is a promising and safe choice for sedation in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Remimazolam is unique because it offers a faster onset and a shorter recovery time compared to traditional sedatives like midazolam, which are commonly used for pediatric sedation. This rapid action can be particularly beneficial for children, ensuring they experience less anxiety and discomfort during medical procedures. Additionally, remimazolam is less likely to accumulate in the body, reducing the risk of prolonged sedation or adverse effects, which is especially important in vulnerable pediatric patients. Researchers are excited about its potential to provide safer, more efficient sedation with fewer side effects, making medical visits less distressing for both kids and parents.

What evidence suggests that remimazolam might be an effective treatment for sedation in children?

Research has shown that remimazolam serves as an effective sedative for children undergoing medical procedures. Studies indicate it causes fewer heart and blood pressure issues compared to propofol. Additionally, it reduces the risk of emergence delirium, the confusion some children experience upon waking from sedation. Early evidence suggests it is safer and more reliable than traditional sedatives, making remimazolam a promising choice for sedating children. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with acute lymphoblastic leukemia needing sedation for medical procedures. In the US, it's for those aged 3-17; in Europe, from birth to <18 years. Participants must be able to breathe on their own during sedation and girls of childbearing age must use effective birth control. It excludes emergencies, known drug allergies, active organ failures, airway abnormalities that complicate emergency procedures, neuromuscular diseases, sleep apnoea or cardiac issues.

Inclusion Criteria

Negative pregnancy test at screening and on treatment day

I, and if applicable, my parent(s), agree to participate in the trial.

I am a child aged 3 to 17, scheduled for a medical procedure not related to this trial.

Exclusion Criteria

I have airway issues that could complicate emergency breathing help.

I am currently experiencing heart failure.

I have an active muscle or nerve disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Participants receive intravenous remimazolam for sedation during diagnostic and/or therapeutic procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Remimazolam

Trial Overview The trial tests intravenous remimazolam's ability to safely induce and maintain sedation in pediatric patients undergoing various medical procedures. The goal is to find out if this medication can keep children comfortably asleep without affecting their breathing during short-term treatments lasting up to two hours.

How Is the Trial Designed?

Group I: All Patients Experimental Treatment 1 Intervention

All paediatric patients undergoing diagnostic and/or therapeutic procedures

Who Is Running the Clinical Trial?

Acacia Pharma Ltd

Lead Sponsor

Trials

18

Recruited

4,700+

Paion UK Ltd.

Industry Sponsor

Trials

16

Recruited

2,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10532234/

Remimazolam for Pediatric Procedural Sedation Our findings suggest that remimazolam, when supplemented with propofol or ketamine, could offer a safe and effective pathway for administering procedural ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12500429/

Remimazolam in pediatric anesthesia: a systematic review for ... Remimazolam demonstrated superior hemodynamic stability vs. propofol (cardiovascular complications: RR 0.30, 95% CI 0.20–0.46) and reduced emergence delirium by ...

3. link.springer.com link.springer.com/article/10.1007/s44254-025-00090-w

Remimazolam in children: a comprehensive narrative review Early pediatric data suggest it may offer significant advantages over traditional sedatives, including enhanced predictability, improved safety, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07036419

Study Details | NCT07036419 | A Trial of Remimazolam for ... The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients. Official ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0329861

Remimazolam for anesthesia and sedation in pediatric ... This review will provide a comprehensive evidence map of remimazolam in pediatric ambulatory anesthesia, highlighting research distribution, clinical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04851717

NCT04851717 | Investigation of Remimazolam in Children ... To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or ...

7. apsf.org apsf.org/article/remimazolam-patient-safety-considerations-of-a-novel-practice-changing-drug-in-perioperative-medicine/

Remimazolam: Patient Safety Considerations of a Novel ... Remimazolam appears to be a relatively safe medication. However, we likely do not fully understand the impact of remimazolam on clinical outcomes after specific ...

8. mdpi.com mdpi.com/2077-0383/12/18/5937

Remimazolam for Pediatric Procedural Sedation Our findings suggest that remimazolam, when supplemented with propofol or ketamine, could offer a safe and effective pathway for administering procedural ...