PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated with Midazolam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

749 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-06-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Summary

The premedication is one of the essential sides of pediatrics anesthesia. Midazolam is considered such as standard these days. Children may develope a paradoxical reaction to benzodiazepines which is one of the adverse effect. Its incidence is unknown. The hypothesis is, in pediatric patients undergoing general anesthesia premedicated with oral midazolam, the incidence of the paradoxical reaction is 10%. Primary Goal of the study is to find out the incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia. Secondary goal is to find out the incidence of the paradoxical reactions in children of different age groups. For the assessment, the study uses parameters: RASS, blood pressure, heart rate, PAED, PSAS, MAS and VAS.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

NCT06419543

Endoscopy, Gastrointestinal

COMPLETED NA

Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

NCT04135014

Anxiety

UNKNOWN PHASE4

Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

NCT06979791

Preoperative Anxiety Experienced by the Pediatric Patient Preoperative Anxiety

NOT_YET_RECRUITING PHASE2

a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

NCT04356638

Anxiety State Perioperative/Postoperative Complications

RECRUITING PHASE3

Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

NCT04273035

Perioperative Anxiety Preanesthetic Medication Inhalation Anesthesia +4 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The premedication is one of the essential sides of pediatrics anesthesia. Midazolam is considered such as standard these days. Children may develope a paradoxical reaction to benzodiazepines which is one of the adverse effect.

The paradoxical reaction is an abnormal stimulative reaction to benzodiazepines characterized by hallucination, disorientation, alteration in perception and recognition as well as the escalation of negative emotion- uncalming crying, agitation, restlessness, and hostility. Risk factors for the development of the paradoxical reaction are young age, mental illness, genetic disposition, male sex, alcohol abuse, and higher midazolam doses.

The incidence of paradoxical reaction is referred to be about 1-10%, in some specific groups even more (about 29%). The exact incidence is still not known since the accurate definition of paradoxical reaction is still missing.

Primary Goal of the study is find out the incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia and incidence of the paradoxical reactions in children of different age groups (3 months-1 year, 1 year-3 years, 3 years-6 years, 6 years-12 years, 12 years-18 years) . The calculated file size is 500 patients. All eligible patients should be evaluated for pre-treatment, pre-anesthesia, immediately prior to anesthesia and anesthesia when RASS above -2. For purpose of the study we have determined the definition of paradoxical reaction as an increase in pulse and/or blood pressure of 20% over pre-premedication , RASS increase by one point or more and raising PEAD to 10 or more points. The paradoxical reaction criteria are met if at least two points of the definition are met. Change within 45min. after premedication.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacological Action

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

age from 3 months to 18 years

* oral midazolam premedication for at least 30 minutes before rating
* patient undergoing deep sedation / general anesthesia diagnostic or surgery with RASS -4 or more

Exclusion Criteria

\- personal history of benzodiazepines using

* moderate or severe respiratory insufficiency
* myopathy, neuromuscular transmission disorders
* moderate or severe CNS disability, including brain tumors, uncontrolled convulsions
* age \<3 months and\> 18 years
* pregnancy

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No