Pediatric SedationNCT07461376
Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.
A study testing Oral Clonidine (OC) in people with Pediatric Sedation and Clonidine Sedation, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Sedation, Clonidine Sedation, Ketamine Sedation
- What is being tested?
- Oral Clonidine (OC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
- ASA I and II
Who cannot join
- Parents refusal.
- ASA risk score >II
- Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
- Allergy from the used drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, Giza Governorate
Omnia Y Kamel, Doctorate degree, 01270130326, omniayehiakamel90@gmail.com
About this study
Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Read the detailed description
Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.
Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.
Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.
Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.
- Conditions
- Pediatric Sedation, Clonidine Sedation, Ketamine Sedation
- Being tested
- Oral Clonidine (OC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Clonidine (OC)Drug
Also called Oral Ketamine (OK)
compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group Oral Clonidine (OC) | Active comparator | This group of children will be premedicated with oral clonidine (4 mic/Kg) 60 minutes preoperatively in a sip of water. Receives: Drug: Oral Clonidine (OC) |
| Group Oral Ketamine (OK) | Active comparator | This group of children will be premedicated with oral Ketamine (10 mg/Kg) 60 minutes preoperatively in a sip of water. Receives: Drug: Oral Clonidine (OC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation level
using Ramsey sedation scale (RSS)
Measured: 60 minutes after administration of the drug (at time of separation from the parents).
Secondary outcomes (2)
Fentanyl administration.
Need and timing of fentanyl administration intraoperatively.
Measured: at 10, 20, 30, 40, 50 minutes until the end of the surgery
Postoperative emergence delirium
assessed at PACU every 15 minutes for 1 hour using pediatric anesthesia emergency and delirium scale (PAED).
Measured: Postoperative at 15, 30, 45 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Apr 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SedationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- A randomized controlled double blinded study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Yahia El Sayed Kamel, Cairo University
- Investigators
- Nevine M Gouda, Professor, Study chair, Cairo UniversitySherif M Soaida, Assistant Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461376
- Sponsor's protocol ID
- Pediatric Sedation
- Status last verified
- Mar 2026
- First submitted
- 16 May 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.
- ClinicalTrials.gov ID
- NCT07461376
- Acronym / sponsor ID
- Pediatric Sedation
- Conditions
- Pediatric Sedation, Clonidine Sedation, Ketamine Sedation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.
Detailed description
Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.
Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.
Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.
Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled double blinded study
| Arm | Type | Receives |
|---|---|---|
| Group Oral Clonidine (OC) | Active comparator | Drug: Oral Clonidine (OC)This group of children will be premedicated with oral clonidine (4 mic/Kg) 60 minutes preoperatively in a sip of water. |
| Group Oral Ketamine (OK) | Active comparator | Drug: Oral Clonidine (OC)This group of children will be premedicated with oral Ketamine (10 mg/Kg) 60 minutes preoperatively in a sip of water. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
- ASA I and II
Key exclusion criteria (4 listed)
- Parents refusal.
- ASA risk score >II
- Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
- Allergy from the used drugs.
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 Clonidine (OC)Also: Oral Ketamine (OK)compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery. | Drug | Group Oral Clonidine (OC), Group Oral Ketamine (OK) |
Primary outcome
Sedation level
Time frame: 60 minutes after administration of the drug (at time of separation from the parents).
using Ramsey sedation scale (RSS)
2 secondary outcomes
Fentanyl administration.
Time frame: at 10, 20, 30, 40, 50 minutes until the end of the surgery
Postoperative emergence delirium
Time frame: Postoperative at 15, 30, 45 and 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- 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.
Nevine M Gouda, Professor study chair
Cairo University
Sherif M Soaida, Assistant Professor study director
Cairo University
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 Clonidine (OC) in people with Pediatric Sedation and Clonidine Sedation, run by Cairo 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: looking for participants now, as of the sponsor's last update on 10 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Y Kamel, Doctorate degree (01270130326, omniayehiakamel90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation level (time frame: 60 minutes after administration of the drug (at time of separation from the parents).). 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 10 Mar 2026.