Pharmacological ActionPARADOXNCT04190537
PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated with Midazolam
An observational study of Pharmacological Action, run by Masaryk Hospital Usti nad Labem at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Pharmacological Action
- How many people
- 749 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2019to 16 Jun 2021
- Phase
- Observational
- 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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All eligible patients should be evaluated for pre-treatment, pre-anesthesia, immediately prior to anesthesia and anesthesia when RASS above -2
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Pharmacological Action
- Keywords
- Paradoxial reaction midazolam
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia.
Investigate the incidence of paradoxical reactions after administration of midazolam in the pediatric population
Measured: Change within 45min. after premedication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Sep 2019
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Usti nad Labem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Vojtisek, Masaryk Hospital Usti nad Labem
- Investigators
- Petr Vojtisek, doctor, Study chair, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190537
- Sponsor's protocol ID
- 273/15
- Acronym
- PARADOX
- Status last verified
- Oct 2024
- First submitted
- 5 Dec 2019
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon YE. Paradoxical reaction to midazolam in children. Korean J Anesthesiol. 2013 Jul;65(1):2-3. doi: 10.4097/kjae.2013.65.1.2. No abstract available.
PubMed 23904931Shin YH, Kim MH, Lee JJ, Choi SJ, Gwak MS, Lee AR, Park MN, Joo HS, Choi JH. The effect of midazolam dose and age on the paradoxical midazolam reaction in Korean pediatric patients. Korean J Anesthesiol. 2013 Jul;65(1):9-13. doi: 10.4097/kjae.2013.65.1.9. Epub 2013 Jul 19.
PubMed 23904933Tobin JR. Paradoxical effects of midazolam in the very young. Anesthesiology. 2008 Jan;108(1):6-7. doi: 10.1097/01.anes.0000296717.85521.b5. No abstract available.
PubMed 18156876McKenzie WS, Rosenberg M. Paradoxical reaction following administration of a benzodiazepine. J Oral Maxillofac Surg. 2010 Dec;68(12):3034-6. doi: 10.1016/j.joms.2010.06.176. Epub 2010 Oct 14. No abstract available.
PubMed 20950912
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated with Midazolam
- ClinicalTrials.gov ID
- NCT04190537
- Acronym / sponsor ID
- PARADOX / 273/15
- Conditions
- Pharmacological Action
- Keywords
- Paradoxial reaction midazolam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- Masaryk Hospital Usti nad LabemUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 9 Dec 2019 (actual)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All eligible patients should be evaluated for pre-treatment, pre-anesthesia, immediately prior to anesthesia and anesthesia when RASS above -2
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia.
Time frame: Change within 45min. after premedication
Investigate the incidence of paradoxical reactions after administration of midazolam in the pediatric population
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 9 Oct 2024.
- Background: PubMed 23904931Moon YE. Paradoxical reaction to midazolam in children. Korean J Anesthesiol. 2013 Jul;65(1):2-3. doi: 10.4097/kjae.2013.65.1.2. No abstract available.
- Background: PubMed 23904933Shin YH, Kim MH, Lee JJ, Choi SJ, Gwak MS, Lee AR, Park MN, Joo HS, Choi JH. The effect of midazolam dose and age on the paradoxical midazolam reaction in Korean pediatric patients. Korean J Anesthesiol. 2013 Jul;65(1):9-13. doi: 10.4097/kjae.2013.65.1.9. Epub 2013 Jul 19.
- Background: PubMed 18156876Tobin JR. Paradoxical effects of midazolam in the very young. Anesthesiology. 2008 Jan;108(1):6-7. doi: 10.1097/01.anes.0000296717.85521.b5. No abstract available.
- Background: PubMed 20950912McKenzie WS, Rosenberg M. Paradoxical reaction following administration of a benzodiazepine. J Oral Maxillofac Surg. 2010 Dec;68(12):3034-6. doi: 10.1016/j.joms.2010.06.176. Epub 2010 Oct 14. No abstract available.
- Individual participant dataSharing planned: No
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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.
Petr Vojtisek, doctor study chair
Masaryk Hospital Usti nad Labem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacological Action, run by Masaryk Hospital Usti nad Labem at 1 site in Czechia.
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 6 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 Oct 2024. 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 Czechia. 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.
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?
Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia. (time frame: Change within 45min. after premedication). 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 NCT04190537, which also lists 4 linked publications.
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 Oct 2024.