Inguinal Hernia RepairNCT06389318
Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair
A study testing oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline in people with Inguinal Hernia Repair, run by Benha University at 1 site in Egypt.
Trial summary
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2023to 24 Apr 2024
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 2 to 7
- American Society of Anaesthesiology (ASA) І and П scheduled for inguinal hernia repair
Who cannot join
- sensitivity to dexmedetomidine or midazolam,
- infection of the upper respiratory tract,
- severe liver or kidney disease, organ dysfunction,
- cardiac arrhythmia or congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Reducing Parental Separation Anxiety in Children Undergoing Inguinal Hernia Repair: A Randomized Clinical Trial
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients
Read the detailed description
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients.
The administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction.
Chloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate.
Dexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. It produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect.
- Conditions
- Inguinal Hernia Repair
- Being tested
- buccal midazolam +oral placebo syrup, oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline
- Keywords
- Midazolam, Dexmedetomidine, Chloral Hydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccal midazolam +oral placebo syrupDrug
Also called Group A
Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.
oral chloral hydrate,intranasal dexmedetomidine and buccal normal salineDrug
Also called Group B
Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe.
| Study group | Role | What they receive |
|---|---|---|
| buccal midazolam group | Experimental | Children received oral placebo syrup, intranasal 0.9 % normal saline at 0.03 ml/kg and buccal midazolam at 0.1 mg/ kg mixed with simple syrup Receives: Drug: buccal midazolam +oral placebo syrup |
| oral chloral hydrate and intranasal dexmedetomidine group | Experimental | Children received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Receives: Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsay sedation score
The scoring criteria were as follows: (1) patient shows anxiety and restlessness; (2) patient is cooperative, oriented, and quiet; (3) patient is responsive to instructions; (4) patient shows somnolence and responsive to the tapping of the glabella or to loud auditory stimuli; (5) patient shows somnolence and unresponsive to the tapping of the glabella or to loud auditory stimuli; and (6) patient shows somnolence without any response.
Measured: RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing
Secondary outcomes (1)
Parental separation anxiety scale
Parental separation anxiety scale was determined when the child was separated from the parents according to four levels:
- easy to separate
- sobbing but easy to cease
- crying loudly and difficult to stop but without holding the parents and not letting them go
- crying loudly and holding the parents and not willing to let them go. PSAS scores of 1 and 2 were considered "successful separation from parents
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start26 Mar 2023
- Primary completion26 Mar 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- More trials run by Benha 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mousa, Benha University
- Investigators
- Ramy Saleh, MD, Principal investigator, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389318
- Sponsor's protocol ID
- RC 29-11-2023
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available upon reasonable request from the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Reducing Parental Separation Anxiety in Children Undergoing Inguinal Hernia Repair: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06389318
- Acronym / sponsor ID
- RC 29-11-2023
- Conditions
- Inguinal Hernia Repair
- Keywords
- Midazolam, Dexmedetomidine, Chloral Hydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 29 Apr 2024 (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.
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients
Detailed description
Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients.
The administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction.
Chloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate.
Dexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. It produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture)
| Arm | Type | Receives |
|---|---|---|
| buccal midazolam group | Experimental | Drug: buccal midazolam +oral placebo syrupChildren received oral placebo syrup, intranasal 0.9 % normal saline at 0.03 ml/kg and buccal midazolam at 0.1 mg/ kg mixed with simple syrup |
| oral chloral hydrate and intranasal dexmedetomidine group | Experimental | Drug: oral chloral hydrate,intranasal dexmedetomidine and buccal normal salineChildren received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 2 to 7
- American Society of Anaesthesiology (ASA) І and П scheduled for inguinal hernia repair
Key exclusion criteria (4 listed)
- sensitivity to dexmedetomidine or midazolam,
- infection of the upper respiratory tract,
- severe liver or kidney disease, organ dysfunction,
- cardiac arrhythmia or congenital heart disease
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 |
|---|---|---|
| buccal midazolam +oral placebo syrupAlso: Group AChildren received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe. | Drug | buccal midazolam group |
| oral chloral hydrate,intranasal dexmedetomidine and buccal normal salineAlso: Group BChildren received oral chloral hydrate (Chloral Hydrate mixture, concentration at 0.5gm/5ml, 250 ml bottle, prepared at abo Elreesh pharmacy, Elmoneerah , Egypt) at 50 mg /kg, intranasal dexmedetomidine at 2 μg/kg and buccal normal saline. Dexmedetomidine used was preservative-free dexmedetomidine (Precedex, 2ml ampoule,100 ug /ml, Hospira, Inc, Rocky Mount, USA) in a concentration of 100 μg/mL. Undiluted drug was withdrawn into a 1 mL tuberculin syringe. | Drug | oral chloral hydrate and intranasal dexmedetomidine group |
Primary outcome
Ramsay sedation score
Time frame: RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing
The scoring criteria were as follows: (1) patient shows anxiety and restlessness; (2) patient is cooperative, oriented, and quiet; (3) patient is responsive to instructions; (4) patient shows somnolence and responsive to the tapping of the glabella or to loud auditory stimuli; (5) patient shows somnolence and unresponsive to the tapping of the glabella or to loud auditory stimuli; and (6) patient shows somnolence without any response.
1 secondary outcome
Parental separation anxiety scale
Time frame: Preoperatively
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 17 May 2024.
- Individual participant dataSharing planned: No. The data will be available upon reasonable request from the principle investigator
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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.
Ramy Saleh, MD principal investigator
Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline in people with Inguinal Hernia Repair, run by Benha 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 2 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: finished, as of the sponsor's last update on 17 May 2024. 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. 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?
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?
Ramsay sedation score (time frame: RSSs were recorded just immediately before and at 10 minutes , 20 minutes , 30 minutes after dosing). 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 17 May 2024.