Autistic DisorderPhase 4NCT04270708
Intranasal Dexmedetomidine vs Oral Triclofos Sodium for EEG in Children With Autism
A Phase 4 study testing Dexmedetomidine and Triclofos 100 MG/ML in people with Autistic Disorder, run by Rabin Medical Center.
Trial summary
Children with Autistic Spectrum Disorder (ASD) often undergo an Electroencephalography (EEG) as part of routine work up. These children present a challenge to successful EEG execution, due to a lack of co-operation, and thus, are often in need of sedation. Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Dexmedetomidine and Triclofos 100 MG/ML
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Aug 2022
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 4-18 yrs referred for an EEG under sedation..
- A Neurologist derived diagnosis of Autistic Spectrum Disorder (ASD).
- ASA 1 or 2
Who cannot join
- Allergy to study drug
- Congenital heart disease, bradycardia < 60 or know arrhythmia/AV block.
- Vasoactive drugs or treatment for arterial HTN.
- Known Renal dysfunction Creatinine Clearance < 30% or known Liver dysfunction (Elevated LFT's).
- Concurrent Treatment with drugs know to interact with Dexmedetomidine:
- Atipical Antipsychotics / Phenothiazines
Show all 13Show fewer
- Tricyclic anti-depressents
- Lacosamide treatment - Antiepileptic.
- PDE V inhibitors (Viagra)
- Beta-blockers
- Phenothiazines
- First generation Anti-histamines
- Significant rhinorrhea.
About this study
Official title: Intranasal Dexmedetomidine vs Oral Triclofos Sodium Sedation for Children With Autism Undergoing Electroencephalograms - A Randomized Controlled Trial.
Children with Autistic Spectrum Disorder (ASD) often undergo an Electroencephalography (EEG) as part of routine work up. These children present a challenge to successful EEG execution, due to a lack of co-operation, and thus, are often in need of sedation. Historically we have used orally administered, Triclofos Sodium (TFS) - pharmacologically and physiologically similar to chloral hydrate, for sedation in this age group. However success using this drug is limited to approximately 75% in those aged 5 years and above, and possibly lower in this age group when associated with a diagnosis of ASD. The medication is often poorly tolerated by the oral route, and involves patient agitation, spiting (with incomplete drug ingestion), and immediate vomiting upon administration. Recently we have introduced Intra-nasal Dexmedetomidine (IN DEX), with an initial impression of much improved drug acceptance and possibly improved efficacy over TFS.
We designed this pilot study, with the aim of comparing efficacy, tolerance of drug administration and adverse events between TFS and IN DEX, with the goal of generating initial results as well as feasibility of recruitment for a larger trial.
Read the detailed description
Study participants will be allocated, amongst patients invited for routine EEG monitoring in the hospitals EEG facility. All patients will be fasted on arrival, with a recommendation to awaken early on the day of the planned examination.
Patients aged 4yrs and above, with a diagnosis of ASD will be allocated and investigated for fulfillment of inclusion and exclusion criteria for study participation. The legal guardians of patients meeting study criteria will be approached for study participation consent. Patients declining consent will be treated with TFS as per current protocol. Patients for whom consent is attained will comprise the study group.
Study group patients will be randomized for treatment and stratified according to age groups: 4-7, 8-12, 12-18. Treatment will consist of 2 alternative pathways:
Oral Trichlofos Sodium (TFS) Pathway:
- Initial Drug dose: Patients will be treated orally with 50mg/kg of TFS to maximum of 2000gr.
- Failure to achieve sedate state 45 minutes after drug administration will enable an additional oral dose of 25mg/kg.
- Patients failing to fall asleep following second drug dose will be regarded as treatment failure.
- Rescue therapy according to physician's choice can be instituted (Dexmed or Neuleptil).
Intranasal Dexmedetomidine (IN DEX) Pathway:
- Initial drug dose: Patients will be treated with IN 3mcg/kg of Dexmedetomidine to max dose of 150mcg. The drug will be delivered through MAD nasal atomizer.
- Failure to achieve sedate state 45 minutes after drug administration will enable an additional dose of IN 1.5mcg/kg by MAD device.
- Paitients failing to fall asleep following second drug dose will be regarded as treatment failure.
- Rescue therapy according to physician's choice can be instituted (Neuleptil not recommended due to drug interactions).
All sedated children will be connected to monitoring including ECG chest leads in addition to oxygen pulse saturation monitoring.
Primary outcome assessment: Sedation depth by UMSS will be assessed by the EEG technician, who will be blinded to the drug used for sedation.
Secondary outcome assessment:
- Satisfaction from sedation depth for completing exam by blinded technician on VAS score.
- EEG motion artifact by interpreting neurologist, blinded to study drug on VAS score.
- All other secondary outcomes from drug administration to discharge, including adverse events and needed interventions, will be documented by the nurse who is not blinded to administered drug.
- ECG monitoring for determination of HR or arrhythmia
- Assessing incidence of bradycardia, hypotension and their severity:
- HR and BP age related normal value chart to be used as reference. b. Bradycardia and Hypotension determined in relation to lower normal value for age: i. Mild<10% decrease from normal value ii. Moderate 10-20% decrease from normal value iii. Severe >20% or signs of hemodynamic compromise Ethics: This study is a comparison of two medications currently under routine use for performing sedated EEG's in our medical center. The study will be authorized by the Rabin Campus Helsinki Committee. Informed consent will be requested from the accompanying legal guardian. Statistics: Based on our experience, we assume a 70% success rate for sedation using TFS and a 90% success rate for IN DEX. Using an alpha of 0.05 and 80% power, two groups of 62 patients would be needed, to demonstrate statistical significance. This trial is planned as a pilot study aimed at assessing drug effects and recruitment rate, over a limited time period of up to 2 year, or up to 200 patiens (100 TFS + 100 IN DEX). Randomization and age stratification: Patient allocation will be determined according to an age stratified randomization table. Patients will be stratified by 3 age groups: 4-7, 8-12, 12-18. Funding: No funding has been allocated for this study. Study will be conducted using routine medications in current practice without additional cost.
- Conditions
- Autistic Disorder
- Being tested
- Dexmedetomidine, Triclofos 100 MG/ML
- Keywords
- Sedation
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients with Autism will be treated with intranasal Dexmedetomidine as a sedative for EEG
Triclofos 100 MG/MLDrug
Patients with Autism will be treated with oral Triclofos as a sedative for EEG
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Intranasal Dexmedetomidine 3mcg/kg Receives: Drug: Dexmedetomidine |
| Triclofos | Active comparator | Oral Triclofos Sodium 50mg/kg Receives: Drug: Triclofos 100 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Sedation Depth
Maximal Sedation Depth by the University of Michigan Sedation Scale (UMSS)
Measured: Within 90 minutes
Technician satisfaction from sedation
Technician Ability to complete exam in satisfactory fashion - VAS score
Measured: Within 90 minutes
Secondary outcomes (7)
Neurologist satisfaction from EEG motion artifact
Neurologist satisfaction from EEG motion artifact - VAS score
Measured: Within 7 days
Compliance with IN vs Oral Delivery
Compliance with IN vs Oral Delivery - Successful drug administration Y/N?
Measured: Immediate upon administration
Resistance to drug administration (1-10 scale)
Resistance to drug administration (1-10 scale): Crying / spitting or Complete or Partial Rejection for TFS/IN DEX
Measured: Immediate upon administration
Achieving sedation following single dose
Achieving sedation following single dose of Dexmed vs TFS
Measured: Within 45 minutes
Achieving sedation following rescue dose
Achieving sedation following additional rescue dose of Dexmed vs TFS
Measured: within 90 minutes
Sedation onset, duration and recovery periods
Sedation onset, duration and recovery periods
Measured: Within 4 hours.
Adverse Events
Sedation associated adverse events
Measured: Within 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eytan Kaplan, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270708
- Sponsor's protocol ID
- 0090-20-RMC
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1.
PubMed 29701730Keller R, Basta R, Salerno L, Elia M. Autism, epilepsy, and synaptopathies: a not rare association. Neurol Sci. 2017 Aug;38(8):1353-1361. doi: 10.1007/s10072-017-2974-x. Epub 2017 Apr 28.
PubMed 28455770Thoresen M, Henriksen O, Wannag E, Laegreid L. Does a sedative dose of chloral hydrate modify the EEG of children with epilepsy? Electroencephalogr Clin Neurophysiol. 1997 Feb;102(2):152-7. doi: 10.1016/s0921-884x(96)96509-1.
PubMed 9060867Nordt SP, Rangan C, Hardmaslani M, Clark RF, Wendler C, Valente M. Pediatric chloral hydrate poisonings and death following outpatient procedural sedation. J Med Toxicol. 2014 Jun;10(2):219-22. doi: 10.1007/s13181-013-0358-z.
PubMed 24532346Sing K, Erickson T, Amitai Y, Hryhorczuk D. Chloral hydrate toxicity from oral and intravenous administration. J Toxicol Clin Toxicol. 1996;34(1):101-6. doi: 10.3109/15563659609020242.
PubMed 8632499Hirsch IA, Zauder HL. Chloral hydrate: a potential cause of arrhythmias. Anesth Analg. 1986 Jun;65(6):691-2. No abstract available.
PubMed 3706808Grissinger M. Chloral Hydrate: Is It Still Being Used? Are There Safer Alternatives? P T. 2019 Aug;44(8):444-459.
PubMed 31447530Kaplan E, Daka A, Weissbach A, Kraus D, Kadmon G, Milkh R, Nahum E. Triclofos Sodium for Pediatric Sedation in Non-Painful Neurodiagnostic Studies. Paediatr Drugs. 2019 Oct;21(5):371-378. doi: 10.1007/s40272-019-00346-6.
PubMed 31292919Mason KP, Lubisch N, Robinson F, Roskos R, Epstein MA. Intramuscular dexmedetomidine: an effective route of sedation preserves background activity for pediatric electroencephalograms. J Pediatr. 2012 Nov;161(5):927-32. doi: 10.1016/j.jpeds.2012.05.011. Epub 2012 Jun 15.
PubMed 22704249Liu H, Sun M, Zhang J, Tian Q, Yu Q, Liu Y, Yang F, Li S, Tu S. Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children. Acta Anaesthesiol Scand. 2019 Aug;63(7):847-852. doi: 10.1111/aas.13372. Epub 2019 Apr 14.
PubMed 30982953Baier NM, Mendez SS, Kimm D, Velazquez AE, Schroeder AR. Intranasal dexmedetomidine: an effective sedative agent for electroencephalogram and auditory brain response testing. Paediatr Anaesth. 2016 Mar;26(3):280-5. doi: 10.1111/pan.12851.
PubMed 26814037Gumus H, Bayram AK, Poyrazoglu HG, Canpolat DG, Per H, Canpolat M, Yildiz K, Kumandas S. Comparison of Effects of Different Dexmedetomidine and Chloral Hydrate Doses Used in Sedation on Electroencephalography in Pediatric Patients. J Child Neurol. 2015 Jul;30(8):983-8. doi: 10.1177/0883073814549582. Epub 2014 Sep 22.
PubMed 25246305Fernandes ML, Oliveira WM, Santos Mdo C, Gomez RS. Sedation for electroencephalography with dexmedetomidine or chloral hydrate: a comparative study on the qualitative and quantitative electroencephalogram pattern. J Neurosurg Anesthesiol. 2015 Jan;27(1):21-5. doi: 10.1097/ANA.0000000000000077.
PubMed 24823763Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. doi: 10.1046/j.1460-9592.2002.00918.x.
PubMed 12472704Poonai N, Spohn J, Vandermeer B, Ali S, Bhatt M, Hendrikx S, Trottier ED, Sabhaney V, Shah A, Joubert G, Hartling L. Intranasal Dexmedetomidine for Procedural Distress in Children: A Systematic Review. Pediatrics. 2020 Jan;145(1):e20191623. doi: 10.1542/peds.2019-1623.
PubMed 31862730
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine vs Oral Triclofos Sodium Sedation for Children With Autism Undergoing Electroencephalograms - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04270708
- Acronym / sponsor ID
- 0090-20-RMC
- Conditions
- Autistic Disorder
- Keywords
- Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
Children with Autistic Spectrum Disorder (ASD) often undergo an Electroencephalography (EEG) as part of routine work up. These children present a challenge to successful EEG execution, due to a lack of co-operation, and thus, are often in need of sedation. Historically we have used orally administered, Triclofos Sodium (TFS) - pharmacologically and physiologically similar to chloral hydrate, for sedation in this age group. However success using this drug is limited to approximately 75% in those aged 5 years and above, and possibly lower in this age group when associated with a diagnosis of ASD. The medication is often poorly tolerated by the oral route, and involves patient agitation, spiting (with incomplete drug ingestion), and immediate vomiting upon administration. Recently we have introduced Intra-nasal Dexmedetomidine (IN DEX), with an initial impression of much improved drug acceptance and possibly improved efficacy over TFS.
We designed this pilot study, with the aim of comparing efficacy, tolerance of drug administration and adverse events between TFS and IN DEX, with the goal of generating initial results as well as feasibility of recruitment for a larger trial.
Detailed description
Study participants will be allocated, amongst patients invited for routine EEG monitoring in the hospitals EEG facility. All patients will be fasted on arrival, with a recommendation to awaken early on the day of the planned examination.
Patients aged 4yrs and above, with a diagnosis of ASD will be allocated and investigated for fulfillment of inclusion and exclusion criteria for study participation. The legal guardians of patients meeting study criteria will be approached for study participation consent. Patients declining consent will be treated with TFS as per current protocol. Patients for whom consent is attained will comprise the study group.
Study group patients will be randomized for treatment and stratified according to age groups: 4-7, 8-12, 12-18. Treatment will consist of 2 alternative pathways:
Oral Trichlofos Sodium (TFS) Pathway:
- Initial Drug dose: Patients will be treated orally with 50mg/kg of TFS to maximum of 2000gr.
- Failure to achieve sedate state 45 minutes after drug administration will enable an additional oral dose of 25mg/kg.
- Patients failing to fall asleep following second drug dose will be regarded as treatment failure.
- Rescue therapy according to physician's choice can be instituted (Dexmed or Neuleptil).
Intranasal Dexmedetomidine (IN DEX) Pathway:
- Initial drug dose: Patients will be treated with IN 3mcg/kg of Dexmedetomidine to max dose of 150mcg. The drug will be delivered through MAD nasal atomizer.
- Failure to achieve sedate state 45 minutes after drug administration will enable an additional dose of IN 1.5mcg/kg by MAD device.
- Paitients failing to fall asleep following second drug dose will be regarded as treatment failure.
- Rescue therapy according to physician's choice can be instituted (Neuleptil not recommended due to drug interactions).
All sedated children will be connected to monitoring including ECG chest leads in addition to oxygen pulse saturation monitoring.
Primary outcome assessment: Sedation depth by UMSS will be assessed by the EEG technician, who will be blinded to the drug used for sedation.
Secondary outcome assessment:
- Satisfaction from sedation depth for completing exam by blinded technician on VAS score.
- EEG motion artifact by interpreting neurologist, blinded to study drug on VAS score.
- All other secondary outcomes from drug administration to discharge, including adverse events and needed interventions, will be documented by the nurse who is not blinded to administered drug.
- ECG monitoring for determination of HR or arrhythmia
- Assessing incidence of bradycardia, hypotension and their severity:
- HR and BP age related normal value chart to be used as reference. b. Bradycardia and Hypotension determined in relation to lower normal value for age: i. Mild<10% decrease from normal value ii. Moderate 10-20% decrease from normal value iii. Severe >20% or signs of hemodynamic compromise Ethics: This study is a comparison of two medications currently under routine use for performing sedated EEG's in our medical center. The study will be authorized by the Rabin Campus Helsinki Committee. Informed consent will be requested from the accompanying legal guardian. Statistics: Based on our experience, we assume a 70% success rate for sedation using TFS and a 90% success rate for IN DEX. Using an alpha of 0.05 and 80% power, two groups of 62 patients would be needed, to demonstrate statistical significance. This trial is planned as a pilot study aimed at assessing drug effects and recruitment rate, over a limited time period of up to 2 year, or up to 200 patiens (100 TFS + 100 IN DEX). Randomization and age stratification: Patient allocation will be determined according to an age stratified randomization table. Patients will be stratified by 3 age groups: 4-7, 8-12, 12-18. Funding: No funding has been allocated for this study. Study will be conducted using routine medications in current practice without additional cost.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIntranasal Dexmedetomidine 3mcg/kg |
| Triclofos | Active comparator | Drug: Triclofos 100 MG/MLOral Triclofos Sodium 50mg/kg |
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 4-18 yrs referred for an EEG under sedation..
- A Neurologist derived diagnosis of Autistic Spectrum Disorder (ASD).
- ASA 1 or 2
Key exclusion criteria (13 listed)
- Allergy to study drug
- Congenital heart disease, bradycardia < 60 or know arrhythmia/AV block.
- Vasoactive drugs or treatment for arterial HTN.
- Known Renal dysfunction Creatinine Clearance < 30% or known Liver dysfunction (Elevated LFT's).
- Concurrent Treatment with drugs know to interact with Dexmedetomidine:
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 |
|---|---|---|
| DexmedetomidinePatients with Autism will be treated with intranasal Dexmedetomidine as a sedative for EEG | Drug | Dexmedetomidine |
| Triclofos 100 MG/MLPatients with Autism will be treated with oral Triclofos as a sedative for EEG | Drug | Triclofos |
Primary outcome
Maximal Sedation Depth
Time frame: Within 90 minutes
Maximal Sedation Depth by the University of Michigan Sedation Scale (UMSS)
Technician satisfaction from sedation
Time frame: Within 90 minutes
Technician Ability to complete exam in satisfactory fashion - VAS score
7 secondary outcomes
Neurologist satisfaction from EEG motion artifact
Time frame: Within 7 days
Compliance with IN vs Oral Delivery
Time frame: Immediate upon administration
Resistance to drug administration (1-10 scale)
Time frame: Immediate upon administration
Achieving sedation following single dose
Time frame: Within 45 minutes
Achieving sedation following rescue dose
Time frame: within 90 minutes
Sedation onset, duration and recovery periods
Time frame: Within 4 hours.
Adverse Events
Time frame: Within 4 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 29701730Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1.
- Results publication: PubMed 28455770Keller R, Basta R, Salerno L, Elia M. Autism, epilepsy, and synaptopathies: a not rare association. Neurol Sci. 2017 Aug;38(8):1353-1361. doi: 10.1007/s10072-017-2974-x. Epub 2017 Apr 28.
- Results publication: PubMed 9060867Thoresen M, Henriksen O, Wannag E, Laegreid L. Does a sedative dose of chloral hydrate modify the EEG of children with epilepsy? Electroencephalogr Clin Neurophysiol. 1997 Feb;102(2):152-7. doi: 10.1016/s0921-884x(96)96509-1.
- Results publication: PubMed 24532346Nordt SP, Rangan C, Hardmaslani M, Clark RF, Wendler C, Valente M. Pediatric chloral hydrate poisonings and death following outpatient procedural sedation. J Med Toxicol. 2014 Jun;10(2):219-22. doi: 10.1007/s13181-013-0358-z.
- Results publication: PubMed 8632499Sing K, Erickson T, Amitai Y, Hryhorczuk D. Chloral hydrate toxicity from oral and intravenous administration. J Toxicol Clin Toxicol. 1996;34(1):101-6. doi: 10.3109/15563659609020242.
- Results publication: PubMed 3706808Hirsch IA, Zauder HL. Chloral hydrate: a potential cause of arrhythmias. Anesth Analg. 1986 Jun;65(6):691-2. No abstract available.
- Results publication: PubMed 31447530Grissinger M. Chloral Hydrate: Is It Still Being Used? Are There Safer Alternatives? P T. 2019 Aug;44(8):444-459.
- Results publication: PubMed 31292919Kaplan E, Daka A, Weissbach A, Kraus D, Kadmon G, Milkh R, Nahum E. Triclofos Sodium for Pediatric Sedation in Non-Painful Neurodiagnostic Studies. Paediatr Drugs. 2019 Oct;21(5):371-378. doi: 10.1007/s40272-019-00346-6.
- Results publication: PubMed 22704249Mason KP, Lubisch N, Robinson F, Roskos R, Epstein MA. Intramuscular dexmedetomidine: an effective route of sedation preserves background activity for pediatric electroencephalograms. J Pediatr. 2012 Nov;161(5):927-32. doi: 10.1016/j.jpeds.2012.05.011. Epub 2012 Jun 15.
- Results publication: PubMed 30982953Liu H, Sun M, Zhang J, Tian Q, Yu Q, Liu Y, Yang F, Li S, Tu S. Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children. Acta Anaesthesiol Scand. 2019 Aug;63(7):847-852. doi: 10.1111/aas.13372. Epub 2019 Apr 14.
- Results publication: PubMed 26814037Baier NM, Mendez SS, Kimm D, Velazquez AE, Schroeder AR. Intranasal dexmedetomidine: an effective sedative agent for electroencephalogram and auditory brain response testing. Paediatr Anaesth. 2016 Mar;26(3):280-5. doi: 10.1111/pan.12851.
- Results publication: PubMed 25246305Gumus H, Bayram AK, Poyrazoglu HG, Canpolat DG, Per H, Canpolat M, Yildiz K, Kumandas S. Comparison of Effects of Different Dexmedetomidine and Chloral Hydrate Doses Used in Sedation on Electroencephalography in Pediatric Patients. J Child Neurol. 2015 Jul;30(8):983-8. doi: 10.1177/0883073814549582. Epub 2014 Sep 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Triclofos 100 MG/ML in people with Autistic Disorder, run by Rabin Medical Center.
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 13 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Maximal Sedation Depth (time frame: Within 90 minutes). The study lists 2 primary outcomes in all. 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 NCT04270708, which also lists 18 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 17 Feb 2020.