PediatricCODKMPCISNCT06879496
Comparison of Oral Dexmedetomidine, Ketamine Versus Midazolam for Premedication in Children Undergoing Injuinal Surgeries
A study testing Oral ketamin, Oral Midazolam and Oral dexmedetomidine in people with Pediatric and Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between oral dexmedetomidine, Ketamine or midazolam for premedication in children undergoing inguinal hernia surgeries. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Anesthesia
- What is being tested?
- Oral ketamin, Oral Midazolam and Oral dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2025to 10 Sep 2025
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3-7 years.
- Both sexes.
- American society of anesthesiologists (ASA) physical status (I-II).
Who cannot join
- Parents refusal.
- Patients with known allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Use of psychotropic medication, and mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare between oral dexmedetomidine, Ketamine or midazolam for premedication in children undergoing inguinal hernia surgeries.
Read the detailed description
This randomized, double-blind comparative study will be carried out on 60 children undergoing inguinal hernia surgeries admitted to Tanta University Hospitals over a period from Mars 2025-September 2025.
An informed written consent will be obtained from the parents of these children. Every patient will receive an explanation of the purpose of the study and will have a secret code number.
Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time.
Randomization and blinding:
Patients who meet the previous criteria will be enrolled in the study. Patients will be randomly classified into three equal groups: 20 patients will be enrolled in each group using computer generated random number in closed sealed, opaque envelopes:
(Group K): Patients will receive orally ketamin 6 mg/kg. (Group D): Patients will receive orally dexmedetomidine 4 mcg kg -1 (Group M): Patients will receive orally midazolam 0.5 mg kg -1. Patients and outcome assessors involved will be blinded to the study allocation and outcomes.
Study protocol:
Before operation, all patients will receive Groups M and D, K will receive an oral administration of 0.2 mg/kg of midazolam (up to a maximum of 15 mg) and 4 µg/kg of dexmedetomidine, 6mg ketamine respectively mixed with apple juice to make a final volume of 3-5 ml, in the preoperative holding area 40 min prior to anesthesia induction.
General anesthesia will be induced. Standard monitoring included electrocardiography (ECG), end-tidal carbon dioxide, arterial oxygen saturation continuously, pulse oximetry, and non-invasive BP every 5 min.
The anesthetic technique will be standardized in all patients. Anesthesia will be induced with sevoflurane 8% in oxygen 100% via a Jackson Rees breathing circuit. An i.v. cannula will be placed after induction of anesthesia. Patients then will receive i.v. propofol 1 mg kg-1 and a laryngeal Mask Airway will be applied.
Anesthesia will be maintained with sevoflurane in a 50% oxygen/air mixture. Spontaneous breathing will be maintained during the procedure. No other sedatives or opioids will be administered during the procedure. At the end of the procedure, the laryngeal mask will be removed, and the child will be transferred to the PACU once the airway will be maintained spontaneously and there will be no hemodynamic instability.
- Conditions
- Pediatric, Anesthesia
- Being tested
- Oral ketamin, Oral Midazolam, Oral dexmedetomidine
- Keywords
- Ketamin, Midazolam, Dexmedetomidine, Oral, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ketaminDrug
Patients will be received oral ketamine before operation
Oral MidazolamDrug
Patients will be received oral Midazolam
Oral dexmedetomidineDrug
Patients will be received oral dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Group K | Active comparator | Patients will receive orally ketamin 6 mg/kg. Receives: Drug: Oral ketamin |
| Group D | Active comparator | Patients will receive orally dexmedetomidine 4 mcg kg -1 Receives: Drug: Oral dexmedetomidine |
| Group M | Active comparator | Patients will receive orally midazolam 0.5 mg kg -1. Receives: Drug: Oral Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
five-point sedation score
Measured: on arrival in the operating room 30 min after end of study drug administration.
Secondary outcomes (1)
Secondary outcome
FLACC score Postoperative face, legs, activity, cry, and consolability (FLACC) scale.
Measured: Till 1 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 Mar 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zakarea Wfa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879496
- Sponsor's protocol ID
- 36264PR1102/2/25
- Acronym
- CODKMPCIS
- Status last verified
- Jan 2026
- First submitted
- 10 Mar 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Dexmedetomidine, Ketamine Versus Midazolam for Premedication in Children Undergoing Injuinal Surgeries
- ClinicalTrials.gov ID
- NCT06879496
- Acronym / sponsor ID
- CODKMPCIS / 36264PR1102/2/25
- Conditions
- Pediatric, Anesthesia
- Keywords
- Ketamin, Midazolam, Dexmedetomidine, Oral, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 17 Mar 2025 (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 aim of this study is to compare between oral dexmedetomidine, Ketamine or midazolam for premedication in children undergoing inguinal hernia surgeries.
Detailed description
This randomized, double-blind comparative study will be carried out on 60 children undergoing inguinal hernia surgeries admitted to Tanta University Hospitals over a period from Mars 2025-September 2025.
An informed written consent will be obtained from the parents of these children. Every patient will receive an explanation of the purpose of the study and will have a secret code number.
Research results will be only used for scientific purpose. Any unexpected risk/s appearing during the course of research will be clarified to the participants and to the ethical committee on time.
Randomization and blinding:
Patients who meet the previous criteria will be enrolled in the study. Patients will be randomly classified into three equal groups: 20 patients will be enrolled in each group using computer generated random number in closed sealed, opaque envelopes:
(Group K): Patients will receive orally ketamin 6 mg/kg. (Group D): Patients will receive orally dexmedetomidine 4 mcg kg -1 (Group M): Patients will receive orally midazolam 0.5 mg kg -1. Patients and outcome assessors involved will be blinded to the study allocation and outcomes.
Study protocol:
Before operation, all patients will receive Groups M and D, K will receive an oral administration of 0.2 mg/kg of midazolam (up to a maximum of 15 mg) and 4 µg/kg of dexmedetomidine, 6mg ketamine respectively mixed with apple juice to make a final volume of 3-5 ml, in the preoperative holding area 40 min prior to anesthesia induction.
General anesthesia will be induced. Standard monitoring included electrocardiography (ECG), end-tidal carbon dioxide, arterial oxygen saturation continuously, pulse oximetry, and non-invasive BP every 5 min.
The anesthetic technique will be standardized in all patients. Anesthesia will be induced with sevoflurane 8% in oxygen 100% via a Jackson Rees breathing circuit. An i.v. cannula will be placed after induction of anesthesia. Patients then will receive i.v. propofol 1 mg kg-1 and a laryngeal Mask Airway will be applied.
Anesthesia will be maintained with sevoflurane in a 50% oxygen/air mixture. Spontaneous breathing will be maintained during the procedure. No other sedatives or opioids will be administered during the procedure. At the end of the procedure, the laryngeal mask will be removed, and the child will be transferred to the PACU once the airway will be maintained spontaneously and there will be no hemodynamic instability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group K | Active comparator | Drug: Oral ketaminPatients will receive orally ketamin 6 mg/kg. |
| Group D | Active comparator | Drug: Oral dexmedetomidinePatients will receive orally dexmedetomidine 4 mcg kg -1 |
| Group M | Active comparator | Drug: Oral MidazolamPatients will receive orally midazolam 0.5 mg kg -1. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 3-7 years.
- Both sexes.
- American society of anesthesiologists (ASA) physical status (I-II).
Key exclusion criteria (5 listed)
- Parents refusal.
- Patients with known allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Use of psychotropic medication, and mental retardation.
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 ketaminPatients will be received oral ketamine before operation | Drug | Group K |
| Oral MidazolamPatients will be received oral Midazolam | Drug | Group M |
| Oral dexmedetomidinePatients will be received oral dexmedetomidine | Drug | Group D |
Primary outcome
Primary outcome
Time frame: on arrival in the operating room 30 min after end of study drug administration.
five-point sedation score
1 secondary outcome
Secondary outcome
Time frame: Till 1 hour after operation
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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ketamin, Oral Midazolam and Oral dexmedetomidine in people with Pediatric and Anesthesia, run by Tanta 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 3 inclusion and 5 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 13 Jan 2026. 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?
Primary outcome (time frame: on arrival in the operating room 30 min after end of study drug administration.). 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 Jan 2026.