Emergence AgitationPhase 4EDIRANCT03426020
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
A Phase 4 study testing Oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor and Play game (PC fishing game) in people with Emergence Agitation, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy . Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor and Play game (PC fishing game)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2018to 10 Jun 2018
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I-II
- Pediatric patients
- Elective surgery
- Adenotonsillectomi
Who cannot join
- Cronicdesease
- Mental retarde
- Hearing and visual impaired
- Prematurite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .
Read the detailed description
Compare the effects of
0.5 mg/kg oral midazolam,
watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and
playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"
Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
- Conditions
- Emergence Agitation
- Being tested
- Oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor, Play game (PC fishing game)
- Keywords
- Premedication, Pediatric patients, Emergence agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral midazolamOther
Also called Demizolam
0.5 mg/kg oral midazolam administered 20 minutes before induction
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyorOther
patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
Play game (PC fishing game)Other
Patients will be played a simple PC game (a fishing game) 20 minutes before induction
| Study group | Role | What they receive |
|---|---|---|
| Oral midazolam (Demizolam®) | Active comparator | To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). Receives: Other: Oral midazolam |
| Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor | Active comparator | To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). Receives: Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor |
| Play game (PC fishing game) | Active comparator | To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale). Receives: Other: Play game (PC fishing game) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.
Measured: Postoperative every 5 minutes for 15 minutes
Secondary outcomes (4)
preoperative anxiety
Preoperative anxiety will be evaluated by Modified Yale Preoperative Anxiety Scale ( m-YPAS )scores. Range between 23 to 100. m-YPAS score above 30 is significant to patients anxiety.
Measured: 20 minutea after premedications.
Post operative pain
Postoperative pain will be evaluated by behavioral pain scale FLACC(behavioral pain assesment scale). Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0 = Relaxed and comfortable.
1 - 3 = mild discomfort 4 - 6 = moderate pain 7 - 10 = Severe discomfort or pain or both
Measured: Postoperative every 5 minutes for 15 minutes
Mean arteriel pressure
Mean arteriel pressure, will be measured. Mean blood pressurre range between 66 to 73 mm Hg is considered normal value. 20% increase in baseline value is considered significant.
Measured: Postoperative every 5 minutes for15 minutes
Heart rate
Heart rate range between 80 to 120 beats/minute is considered normal value. %20 percent increase in baseline value is considered significant.
Measured: Postoperative every 5 minutes for15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start20 Feb 2018 (estimated)
- Primary completion30 May 2018 (estimated)
- Study completion10 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426020
- Sponsor's protocol ID
- 27/11/2017 43/20
- Other IDs
- Ministry of Health
- Acronym
- EDIRA
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
- ClinicalTrials.gov ID
- NCT03426020
- Acronym / sponsor ID
- EDIRA / 27/11/2017 43/20
- Conditions
- Emergence Agitation
- Keywords
- Premedication, Pediatric patients, Emergence agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 20 Feb 2018 (estimated)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 10 Jun 2018 (estimated)
- First posted
- 8 Feb 2018 (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.
Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .
Detailed description
Compare the effects of
0.5 mg/kg oral midazolam,
watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and
playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"
Pain evaluated by FLACC (behoviaral pain assesment scale),at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Blood pressure(mmHg), heart rate(beat/min) and SpO2(%) measured and recorded at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Effect of pharmacologic or nonpharmacologic premedication on emergency agitation
| Arm | Type | Receives |
|---|---|---|
| Oral midazolam (Demizolam®) | Active comparator | Other: Oral midazolamTo prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). |
| Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor | Active comparator | Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyorTo prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale). |
| Play game (PC fishing game) | Active comparator | Other: Play game (PC fishing game)To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA I-II
- Pediatric patients
- Elective surgery
- Adenotonsillectomi
Key exclusion criteria (4 listed)
- Cronicdesease
- Mental retarde
- Hearing and visual impaired
- Prematurite
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 |
|---|---|---|
| Oral midazolamAlso: Demizolam0.5 mg/kg oral midazolam administered 20 minutes before induction | Other | Oral midazolam (Demizolam®) |
| Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyorpatients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction. | Other | Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor |
| Play game (PC fishing game)Patients will be played a simple PC game (a fishing game) 20 minutes before induction | Other | Play game (PC fishing game) |
Primary outcome
Emergence agitation
Time frame: Postoperative every 5 minutes for 15 minutes
Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.
4 secondary outcomes
preoperative anxiety
Time frame: 20 minutea after premedications.
Post operative pain
Time frame: Postoperative every 5 minutes for 15 minutes
Mean arteriel pressure
Time frame: Postoperative every 5 minutes for15 minutes
Heart rate
Time frame: Postoperative every 5 minutes for15 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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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.
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 Oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor and Play game (PC fishing game) in people with Emergence Agitation, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 4 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 8 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reyhan Polat (5326734310, reyhanp9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence agitation (time frame: Postoperative every 5 minutes for 15 minutes). 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 8 Feb 2018.