PremedicationPhase 4NCT03357718
Oral Dexmedetomidine vs Midazoam For Premedication
A Phase 4 study testing Precedex and Midazolam in people with Premedication, run by Aydin Adnan Menderes University.
Trial summary
The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Premedication
- What is being tested?
- Precedex and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Jun 2017
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.
Who cannot join
- The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.
About this study
Official title: Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment
The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.
Read the detailed description
The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.
The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.
- Conditions
- Premedication
- Being tested
- Precedex, Midazolam
- Keywords
- premedication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Also called Dexmedetomidine
2 µg/kg oral
MidazolamDrug
Also called Dormicum
0.5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 2 µg/kg Precedex Receives: Drug: Precedex |
| Midazolam | Active comparator | 0.5 mg/kg dormicum Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsey Sedation Scale
Sedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score '1' was considered as unsatisfactory and "≥ 2" was considered as satisfactory sedation.
Measured: 45 minutes after premedication
Secondary outcomes (2)
Parental Separation Anxiety Scale
Behavior of the child on seperation from the parents was assessed according to a four-point scale, i.e., the parental seperation anxiety scale (PSAS): 1= Easy seperation, 2=Whimpers but easily reassured, 3=Cries and cannot be easily reassured, but not clinging to parents, 4=Cries and clinging to parents. A PSAS score of 1 and 2 were considered as 'successful parental seperation'.
Measured: Preoperative
Mask Acceptance Score
Mask acceptance was evaluated using a four-point scale, i.e., mask acceptance scale (MAS):
1=Excellent (unafraid, cooperative, and accepts mask easily), 2=Good (slight fear of mask , easily reassured), 3=Fair (moderate fear of mask, not calmed with reassurance), 4=Poor (terrified, crying, or combative). The score of 1 and 2 considered as 'satisfactory' mask acceptance.
Measured: Before induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Nov 2016
- Primary completion30 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PremedicationStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Retrospective clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
- Investigators
- Sultan KELES, Dr., Principal investigator, Adnan Menderes University Faculty of Dentistry Aydın
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357718
- Sponsor's protocol ID
- 2017/18
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results
Publications
Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
PubMed 28298782
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment
- ClinicalTrials.gov ID
- NCT03357718
- Acronym / sponsor ID
- 2017/18
- Conditions
- Premedication
- Keywords
- premedication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 30 Nov 2017 (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.
The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.
Detailed description
The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.
The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Retrospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Precedex2 µg/kg Precedex |
| Midazolam | Active comparator | Drug: Midazolam0.5 mg/kg dormicum |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.
Key exclusion criteria (1 listed)
- The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.
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 |
|---|---|---|
| PrecedexAlso: Dexmedetomidine2 µg/kg oral | Drug | Dexmedetomidine |
| MidazolamAlso: Dormicum0.5 mg/kg | Drug | Midazolam |
Primary outcome
Ramsey Sedation Scale
Time frame: 45 minutes after premedication
Sedation level is evaluated due to patient behavior. 1= Patient is anxious and agitated or restless or both, 2=Patient is cooperative, oriented, and tranquil, 3=Patient responds to command only, 4=Patient exhibits brisk response to light glabellar tap, 5=Patient exhibits sluggish response to light glabellar tap, 6=Patient exhibits no response.A Ramsay sedation score '1' was considered as unsatisfactory and "≥ 2" was considered as satisfactory sedation.
2 secondary outcomes
Parental Separation Anxiety Scale
Time frame: Preoperative
Mask Acceptance Score
Time frame: Before induction
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 29 May 2020.
- Background: PubMed 28298782Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
- Individual participant dataSharing planned: No. Results
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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.
Sultan KELES, Dr. principal investigator
Adnan Menderes University Faculty of Dentistry Aydın
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precedex and Midazolam in people with Premedication, run by Aydin Adnan Menderes University.
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 1 inclusion and 1 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 29 May 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?
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?
Ramsey Sedation Scale (time frame: 45 minutes 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 NCT03357718, which also lists 1 linked publication.
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 29 May 2020.