Effect of DrugPhase 1NCT05680584
Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy
A Phase 1 study testing Melatonin 3 MG and Hydroxyzine Pill in people with Effect of Drug and Anxiety, run by Minia University at 1 site in Egypt.
Trial summary
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Effect of Drug, Anxiety
- What is being tested?
- Melatonin 3 MG and Hydroxyzine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Jan 2024
- Phase
- Phase 1
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA: class l
- Sex: male and female
- Age: from 3 to 10 years old
- Children scheduled for adenotonsillectomy
Who cannot join
- All children with a history of chronic illness, or developmental delay were excluded from the study
- History of an autoimmune disease
- Concurrent use of immunosuppressive treatment
- Sleep disturbances, speech or communication problems
- allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
- hydroxyzine is contraindicated in patients with acute porphyria
- -
Trial locations and contacts
1 site in 1 country.
Hanafy contact
Egypt1 site, 1 recruiting
- Recruiting
Sarah Omar
Al Minyā, 61111
Sarah Omar, +20100537617, sara.mohamed@mu.edu.eg
About this study
Official title: Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
Read the detailed description
The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.
The primary outcomes:
- Ease of parenteral separation.
- The compliance to anesthesia induction in pediatric patients.
The secondary outcomes:
- Assessment of postoperative pain.
- Time to first analgesic request.
- Conditions
- Effect of Drug, Anxiety
- Being tested
- Melatonin 3 MG, Hydroxyzine Pill, Placebo
- Keywords
- Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 MGDrug
Also called Melatonin
0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia
Hydroxyzine PillDrug
Also called Atarax 10mg
1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia
PlaceboOther
10 ml apple juice 1 hour before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Preoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia Receives: Drug: Melatonin 3 MG |
| Hydroxyzine | Active comparator | Preoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia Receives: Drug: Hydroxyzine Pill |
| placebo | Placebo comparator | 10ml apple juice one hour before induction of anesthesia Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of parenteral separation.
Recorded as excellent, good, fair, or poor when the child is separated from the parent
Measured: 20-30 minutes after administration
The compliance to anesthesia induction in pediatric patients.
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
Measured: one hour after administration
Secondary outcomes (2)
Assessment of postoperative pain
Face, Leg, Activity, Cry, and Consolability (FLACC) Scale from 0 to 10, the lower score is better
Measured: immediately before and at induction procedure
First analgesic request
Paracetamol
Measured: Three hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Minia 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three study groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohamed Aly Omar Mousa, Minia University
- Investigators
- Sarah Omar, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680584
- Sponsor's protocol ID
- 505/2022
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: May share when the study is completed
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in Pediatric Patients Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT05680584
- Acronym / sponsor ID
- 505/2022
- Conditions
- Effect of Drug, Anxiety
- Keywords
- Melatonin, Hydroxyzine, Preoperative Anxiety, Pediatric, Adenotonsillectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 11 Jan 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.
Comparison between the effect of oral Melatonin and Hydroxyzine for Preventing Preoperative Anxiety in pediatric Patients Undergoing Adenotonsillectomy
Detailed description
The aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy.
The primary outcomes:
- Ease of parenteral separation.
- The compliance to anesthesia induction in pediatric patients.
The secondary outcomes:
- Assessment of postoperative pain.
- Time to first analgesic request.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three study groups
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Melatonin 3 MGPreoperative oral melatonin 0.1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
| Hydroxyzine | Active comparator | Drug: Hydroxyzine PillPreoperative oral hydroxyzine 1mg/ kg in 10ml apple juice one hour before induction of anesthesia |
| placebo | Placebo comparator | Other: Placebo10ml apple juice one hour before induction of anesthesia |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA: class l
- Sex: male and female
- Age: from 3 to 10 years old
- Children scheduled for adenotonsillectomy
Key exclusion criteria (7 listed)
- All children with a history of chronic illness, or developmental delay were excluded from the study
- History of an autoimmune disease
- Concurrent use of immunosuppressive treatment
- Sleep disturbances, speech or communication problems
- allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine.
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 |
|---|---|---|
| Melatonin 3 MGAlso: Melatonin0.1 mg/ kg melatonin in 10 ml apple juice 1 hour before induction of anesthesia | Drug | Melatonin |
| Hydroxyzine PillAlso: Atarax 10mg1 mg/ kg hydroxyzine in 10 ml apple juice 1 hour before induction of anesthesia | Drug | Hydroxyzine |
| Placebo10 ml apple juice 1 hour before induction of anesthesia | Other | placebo |
Primary outcome
Ease of parenteral separation.
Time frame: 20-30 minutes after administration
Recorded as excellent, good, fair, or poor when the child is separated from the parent
The compliance to anesthesia induction in pediatric patients.
Time frame: one hour after administration
Assessed by a modified Yale preoperative anxiety scale, the range is from 5 to 22, the lower score is better
2 secondary outcomes
Assessment of postoperative pain
Time frame: immediately before and at induction procedure
First analgesic request
Time frame: Three hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No. May share when the study is completed
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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.
Hanafy contact
Sarah Omar study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin 3 MG and Hydroxyzine Pill in people with Effect of Drug and Anxiety, run by Minia University 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 7 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 27 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sarah Omar, M.D. (+20100537617, sara.mohamed@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of parenteral separation. (time frame: 20-30 minutes after administration). 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?
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 27 Dec 2023.