Anxiety AcuteNCT05766436
Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery
A study testing Dexmedetomidine and Melatonin in people with Anxiety Acute and Emergence Agitation, run by nada moahmed aboelrouse at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case… Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Acute, Emergence Agitation
- What is being tested?
- Dexmedetomidine and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 30 Sep 2023
- Phase
- Interventional
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) physical status I \& II
- both genders,
- ≥ 2 to 10 years,
- scheduled for elective day case surgery under general anesthesia
Who cannot join
- parents' refusal for participation in the study
- ASA III and VI patients with history of chronic illness
- runny nose or upper respiratory tract infection
- Emergency surgeries with hemodynamic instability
- history of allergic reaction to dexmedetomidine or melatonin
- History of prematurity
Show all 11Show fewer
- developmental delay
- central nervous system disorder,
- mental retardation,
- neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
- treatment with anticonvulsants and sedatives
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university hospital
Cairo, Abbasia, 11213
Nada M Aboelrouse, masters, 00201003371346, nadaaboelrouse21@gmail.com
mohamed A Tolba, MD, 01156622298, Mohamedtolba@med.asu.edu.eg
About this study
Official title: Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study
The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.
Read the detailed description
All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline.
after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital
- Conditions
- Anxiety Acute, Emergence Agitation
- Being tested
- Dexmedetomidine, Melatonin, Placebo
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex™ rxlist
receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.
MelatoninDrug
Also called metacyst ™ nerhadou
will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining
PlaceboDrug
Also called normal saline
placebo ODF and 0.9% normal saline nebulizer
| Study group | Role | What they receive |
|---|---|---|
| group D | Active comparator | will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist) Receives: Drug: Dexmedetomidine |
| group M | Active comparator | will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou) Receives: Drug: Melatonin |
| group C | Placebo comparator | will receive placebo ODF and placebo 0.9% normal saline nebulizer Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative anxiety
perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following:
- Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1)
- Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2)
- Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3)
- Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response
Measured: during the patient separation from the caregiver just as the child is going to the operating theater
Secondary outcomes (3)
mask acceptance
calculated according to the mask acceptance scale (MAS) as following : if the Child is calm, cooperative, or asleep the score will be (1) if the child is in Moderate fear of the mask Manageable with reassurance the score will be(2) if the child Cries, combative and needs restraining the score will be (3)
score of (1) means excellent response ,score of (2) means fair response and score of (3) means poor response
Measured: during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision
post anesthesia emergence agitation
will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) with score
1= calm , 2= not calm but could be easily consoled , 3= moderately agitated or restless and not easily calmed , 4 = combative , excited , thrashing around
Measured: first 15 minutes after admission to post- anesthesia care unit
pain score
using Face, leg, activity, cry and Consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia
Measured: during hospital stay up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety AcuteStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nada moahmed aboelrouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nada moahmed aboelrouse, NewGiza University
- Investigators
- Sohair Abbas, MD, Study chair, Ain Shams University, Anesthesia departmentRamy Mahrose, MD, Study director, Ain Shams University, Anesthesia departmentWessam Zaher, MD, Study director, Ain Shams University, Anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766436
- Sponsor's protocol ID
- FWA 000017585
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study
- ClinicalTrials.gov ID
- NCT05766436
- Acronym / sponsor ID
- FWA 000017585
- Conditions
- Anxiety Acute, Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- nada moahmed aboelrouseUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Mar 2023 (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 goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.
Detailed description
All patients will be admitted on the day of the surgery and will be instructed to fast 6 hours before surgery for older patients, as for breast fed patients, they will be instructed for 4 hours for breast feeding and for formula fed patients they will be instructed to fast for 6 hours as recommended by the American society of anesthesiologists. Preoperative assessment will be done before surgery by one of the members of the team who will make sure that the inclusion and exclusion criteria of the patients are considered, and baseline vital signs will be recorded. According to randomization that will be done by envelop concealed allocation , the drug will be administered to the patients by a researcher who will not participate in the evaluation of the patients 30 mins before transfer to the operation room (OR): each group will receive the intervention drug Parents are not allowed to accompany their children to the OR according to the hospital policy. On arrival to the OR department the Parental separation anxiety scale (PSAS) will be calculated on entering the operation room standard monitoring will be commenced including ECG, non-invasive blood pressure and pulse oximetry and baseline measurement will be recorded. Inhalational induction will be then started with sevoflurane and mask acceptance will be calculated according to the mask acceptance scale (MAS) intravenous cannulation will be then established after which each patient will receive 1-2 mg/kg Propofol, 1 µg/kg fentanyl to attenuate the stress of intubation and 0.5mg/kg atracurium after tracheal intubation anesthesia will be maintained with sevoflurane 2-4 MAC During the length of the operation vital data will be recorded at 5 minutes interval. all patients will receive IV paracetamol 15mg/kg and patient would receive 1 µg/kg fentanyl as a rescue dose if vital data increased by >20% of the baseline.
after the completion of surgery extubating will be performed after meeting extubation criteria and patient will be discharged to post-anesthesia care unit (PACU) in for the first 15 min after admission to PACU the post anesthesia emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) during the stay in PACU pain will also be assessed by using FLACC score Discharge from PACU will be done after meeting discharge criteria and the time of discharge will be documented. After discharge pain score will be measured using FLACC score at 15, 30, 60 minutes interval postoperative and the total combustion of postoperative analgesics will be calculated as well as the time of discharge from the hospital
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group D | Active comparator | Drug: Dexmedetomidinewill receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist) |
| group M | Active comparator | Drug: Melatoninwill receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou) |
| group C | Placebo comparator | Drug: Placebowill receive placebo ODF and placebo 0.9% normal saline nebulizer |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of American Society of Anesthesiologists (ASA) physical status I \& II
- both genders,
- ≥ 2 to 10 years,
- scheduled for elective day case surgery under general anesthesia
Key exclusion criteria (11 listed)
- parents' refusal for participation in the study
- ASA III and VI patients with history of chronic illness
- runny nose or upper respiratory tract infection
- Emergency surgeries with hemodynamic instability
- history of allergic reaction to dexmedetomidine or melatonin
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: Precedex™ rxlistreceive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min. | Drug | group D |
| MelatoninAlso: metacyst ™ nerhadouwill receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining | Drug | group M |
| PlaceboAlso: normal salineplacebo ODF and 0.9% normal saline nebulizer | Drug | group C |
Primary outcome
perioperative anxiety
Time frame: during the patient separation from the caregiver just as the child is going to the operating theater
perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: * Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) * Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) * Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) * Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response
3 secondary outcomes
mask acceptance
Time frame: during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision
post anesthesia emergence agitation
Time frame: first 15 minutes after admission to post- anesthesia care unit
pain score
Time frame: during hospital stay up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- 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.
Sohair Abbas, MD study chair
Ain Shams University, Anesthesia department
Ramy Mahrose, MD study director
Ain Shams University, Anesthesia department
Wessam Zaher, MD study director
Ain Shams University, Anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Melatonin in people with Anxiety Acute and Emergence Agitation, run by nada moahmed aboelrouse at 1 site in Egypt.
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 11 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 13 Mar 2023. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada M Aboelrouse, masters (00201003371346, nadaaboelrouse21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative anxiety (time frame: during the patient separation from the caregiver just as the child is going to the operating theater). 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 13 Mar 2023.