PremedicationPhase 4NCT02072083
Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients
A Phase 4 study testing Dexmedetomidine and Ketamine in people with Premedication and Oculocardiac Reflex, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Premedication, Oculocardiac Reflex
- What is being tested?
- Dexmedetomidine and Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Jun 2014
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the pediatric patients undergoing strabismus surgery
- the pediatric patients between 2-11 years old
- ASA physical status I-II
- the patients whose parents give permission for this study
Who cannot join
- a known drud allergy or hypersensitive reaction to drugs used
- mental retardation
- cardiac arrhythmia or congenital cardiac disease
- organ disfunction (liver , kidney)
- nasal pathology
- psychotropic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.
Read the detailed description
Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.
- Conditions
- Premedication, Oculocardiac Reflex
- Being tested
- Dexmedetomidine, Ketamine
- Keywords
- dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
via intranasal route 1 mcg/kg
KetamineDrug
Also called ketalar
via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | intranasal 1mcg/kg Receives: Drug: Dexmedetomidine |
| ketamine | Active comparator | intranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of premedication on ramsey sedation score
after drug administration ramsey sedation scale is evaluate every 5 min.
Measured: 30 min after premedication
Secondary outcomes (3)
the effects of premedication on oculocardiac reflex
the heart rate drops the 20% of the resting rate
Measured: during the surgery
mask acceptance scale
The subject's ability to accept the anesthesia mask is measured using the mask acceptance scale.
Measured: 30 min after sedation
the parenteral separation anxiety scale
The response to the child parent separation is assessed and graded according to a 4 point scale at 30 min.
Measured: 30 min after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremedicationStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, müge yüce yıldırım, TC Erciyes University
- Investigators
- Müge Yüce Yıldırım, resident, Principal investigator, erciyes univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072083
- Sponsor's protocol ID
- 2013/381
- Status last verified
- Feb 2014
- First submitted
- 15 Feb 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Intranasal Midazolam-ketamine Combination for Premedication of Pediatric Patients Undergoing Strabismus Surgery
- ClinicalTrials.gov ID
- NCT02072083
- Acronym / sponsor ID
- 2013/381
- Conditions
- Premedication, Oculocardiac Reflex
- Keywords
- dexmedetomidine, intranasal, strabismus surgery, premedication, oculocardiac reflex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- 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 is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.
Detailed description
Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Dexmedetomidineintranasal 1mcg/kg |
| ketamine | Active comparator | Drug: Ketamineintranasal 7,5 mg/kg ketamine and 0,1 mg/kg midazolam |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- the pediatric patients undergoing strabismus surgery
- the pediatric patients between 2-11 years old
- ASA physical status I-II
- the patients whose parents give permission for this study
Key exclusion criteria (6 listed)
- a known drud allergy or hypersensitive reaction to drugs used
- mental retardation
- cardiac arrhythmia or congenital cardiac disease
- organ disfunction (liver , kidney)
- nasal pathology
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 |
|---|---|---|
| DexmedetomidineAlso: precedexvia intranasal route 1 mcg/kg | Drug | dexmedetomidine |
| KetamineAlso: ketalarvia intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam | Drug | ketamine |
Primary outcome
the efficacy of premedication on ramsey sedation score
Time frame: 30 min after premedication
after drug administration ramsey sedation scale is evaluate every 5 min.
3 secondary outcomes
the effects of premedication on oculocardiac reflex
Time frame: during the surgery
mask acceptance scale
Time frame: 30 min after sedation
the parenteral separation anxiety scale
Time frame: 30 min after sedation
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 14 Apr 2015.
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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.
Müge Yüce Yıldırım, resident principal investigator
erciyes univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Ketamine in people with Premedication and Oculocardiac Reflex, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 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 14 Apr 2015. 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 Turkey (Türkiye). 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.
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?
the efficacy of premedication on ramsey sedation score (time frame: 30 min after premedication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2015.