SedationPhase 1/2DREAM-KidsNCT07180095
Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.
A Phase 1/2 study testing Intranasal dexmedetomidine and Intranasal ketamine in people with Sedation and Preoperative Anxiety Experienced by the Pediatric Patient, run by Liaquat National Hospital & Medical College.
Trial summary
This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Sedation, Preoperative Anxiety Experienced by the Pediatric Patient, Anxiolytic Effect
- What is being tested?
- Intranasal dexmedetomidine and Intranasal ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jul 2026
- Phase
- Phase 1/2
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of Anesthesiologist (ASA) class-I and II
- Children 2-6 years of age undergoing elective surgery
Who cannot join
- Known hypersensitivity to study drugs
- Refusal of consent
- Known renal, hepatic or cardiac dysfunction
- Nasal deformity or pathology
- Recent upper respiratory infection (within 2 weeks)
- Children undergoing neurosurgery or ophthalmic surgery
About this study
Official title: Intranasal Dexmedetomidine Versus Intranasal Ketamine for Preoperative Sedation in Pediatrics
This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general anesthesia.
Read the detailed description
This is a prospective, randomized, double-blind, controlled trial with Minimum 6 months of data collection. Patients will be randomly divided into 2 groups; Group D and Group K with 30 patients in each group. Group D will receive dexmedetomidine 2 mcg/kg intranasal, diluted in normal saline to a total volume of 1 mL and will be administered 0.5 mL per nostril while group K will receive ketamine 2mg/kg intranasal, diluted in normal saline to a total volume of 1 mL similarly divided into two nostrils. The study drugs will be prepared by a second anesthesiologist who will not be involved in subsequent assessments. The calculated dose for each patient will be administered 30 minutes before induction of anesthesia in preoperative holding area in parental/guardian presence. Sedation level will be assessed at 10 minutes interval for the next 30 minutes or until the child will be shifted to the operating room using MOAA/S and ease of parental separation will be scored using PSAS. All patients will be monitored using standard ASA monitoring (ECG, non-invasive blood pressure , pulse oximetry) before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room. All patients will be induced with 6-8% sevoflurane in 100% oxygen and a 24-G IV access will be secured once the child is asleep. Nalbuphine 0.1 mg/kg IV, atracurium 0.5mg/kg IV (or rocuronium 0.6mg/kg if there's contraindication to atracurium). After endotracheal intubation or laryngeal mask airway (LMA) insertion, all patients will be maintained with 50% O2 in air with isoflurane. Ventilation will be adjusted to maintain an end tidal CO2 concentration between 30-40mmHg. All patients will be given IV paracetamol 20mg/kg as part of multimodal analgesia. If heart rate drops <70 bpm, atropine 10mcg/kg I/V will be used and hypotension will be treated with IV adrenaline 10mcg/kg. Neuromuscular blockade will be reversed with 50mcg/kg neostigmine and 10mcg/kg glycopyrolate. After regaining regular and spontaneous breathing, the endotracheal tube or LMA will be removed and the child will be shifted to post-anesthesia care unit (PACU).
- Conditions
- Sedation, Preoperative Anxiety Experienced by the Pediatric Patient, Anxiolytic Effect, Sedation and Analgesia
- Being tested
- Intranasal dexmedetomidine, Intranasal ketamine
- Keywords
- Preoperative Sedation, Hemodynamic changes, Dexmedetomidine, Dexmedetomidine vs Ketamine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
intranasal dexmedetomidine 2mcg/kg
Intranasal ketamineDrug
intranasal ketamine 2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Dexmedetomidine | Active comparator | Received Intranasal Dexmedetomidine Receives: Drug: Intranasal dexmedetomidine |
| Intranasal ketamine | Experimental | Received Intranasal Ketamine. Receives: Drug: Intranasal ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation score as assessed by MOAA/S
Modified Observer's Assessment of Alertness/ Sedation scale (MOAA/S):
6 = Appears alert and awake, responds readily to name spoken in a normal tone 5 = Appears asleep but responds readily to name spoken in a normal tone 4 = Lethargic response to name spoken in a normal tone 3 = Responds only after the name is called loudly or repeatedly 2 = Responds only after mild prodding or shaking
1 = Does not respond to mild prodding or shaking
Measured: 6 months
Secondary outcomes (2)
Ease of parental separation using PSAS
Parental Separation Anxiety Score (PSAS):
- = Excellent (unafraid, cooperative)
- = Good (slight fear or crying, easily reassured)
- = Fair (moderate fear, not quiet with reassurance)
- = Poor (crying, needing restraint)
Measured: 6 months
Incidence of hypotension and bradycardia in the two groups
Intraoperative hypotension and bradycardia will be monitored before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimon Irshad, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180095
- Sponsor's protocol ID
- aimusa00
- Acronym
- DREAM-Kids
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Intranasal Ketamine for Preoperative Sedation in Pediatrics
- ClinicalTrials.gov ID
- NCT07180095
- Acronym / sponsor ID
- DREAM-Kids / aimusa00
- Conditions
- Sedation, Preoperative Anxiety Experienced by the Pediatric Patient, Anxiolytic Effect, Sedation and Analgesia
- Keywords
- Preoperative Sedation, Hemodynamic changes, Dexmedetomidine, Dexmedetomidine vs Ketamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 18 Sep 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.
This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general anesthesia.
Detailed description
This is a prospective, randomized, double-blind, controlled trial with Minimum 6 months of data collection. Patients will be randomly divided into 2 groups; Group D and Group K with 30 patients in each group. Group D will receive dexmedetomidine 2 mcg/kg intranasal, diluted in normal saline to a total volume of 1 mL and will be administered 0.5 mL per nostril while group K will receive ketamine 2mg/kg intranasal, diluted in normal saline to a total volume of 1 mL similarly divided into two nostrils. The study drugs will be prepared by a second anesthesiologist who will not be involved in subsequent assessments. The calculated dose for each patient will be administered 30 minutes before induction of anesthesia in preoperative holding area in parental/guardian presence. Sedation level will be assessed at 10 minutes interval for the next 30 minutes or until the child will be shifted to the operating room using MOAA/S and ease of parental separation will be scored using PSAS. All patients will be monitored using standard ASA monitoring (ECG, non-invasive blood pressure , pulse oximetry) before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room. All patients will be induced with 6-8% sevoflurane in 100% oxygen and a 24-G IV access will be secured once the child is asleep. Nalbuphine 0.1 mg/kg IV, atracurium 0.5mg/kg IV (or rocuronium 0.6mg/kg if there's contraindication to atracurium). After endotracheal intubation or laryngeal mask airway (LMA) insertion, all patients will be maintained with 50% O2 in air with isoflurane. Ventilation will be adjusted to maintain an end tidal CO2 concentration between 30-40mmHg. All patients will be given IV paracetamol 20mg/kg as part of multimodal analgesia. If heart rate drops <70 bpm, atropine 10mcg/kg I/V will be used and hypotension will be treated with IV adrenaline 10mcg/kg. Neuromuscular blockade will be reversed with 50mcg/kg neostigmine and 10mcg/kg glycopyrolate. After regaining regular and spontaneous breathing, the endotracheal tube or LMA will be removed and the child will be shifted to post-anesthesia care unit (PACU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine | Active comparator | Drug: Intranasal dexmedetomidineReceived Intranasal Dexmedetomidine |
| Intranasal ketamine | Experimental | Drug: Intranasal ketamineReceived Intranasal Ketamine. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American society of Anesthesiologist (ASA) class-I and II
- Children 2-6 years of age undergoing elective surgery
Key exclusion criteria (6 listed)
- Known hypersensitivity to study drugs
- Refusal of consent
- Known renal, hepatic or cardiac dysfunction
- Nasal deformity or pathology
- Recent upper respiratory infection (within 2 weeks)
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 |
|---|---|---|
| Intranasal dexmedetomidineintranasal dexmedetomidine 2mcg/kg | Drug | Intranasal Dexmedetomidine |
| Intranasal ketamineintranasal ketamine 2mg/kg | Drug | Intranasal ketamine |
Primary outcome
Sedation score as assessed by MOAA/S
Time frame: 6 months
Modified Observer's Assessment of Alertness/ Sedation scale (MOAA/S): 6 = Appears alert and awake, responds readily to name spoken in a normal tone 5 = Appears asleep but responds readily to name spoken in a normal tone 4 = Lethargic response to name spoken in a normal tone 3 = Responds only after the name is called loudly or repeatedly 2 = Responds only after mild prodding or shaking 1 = Does not respond to mild prodding or shaking
2 secondary outcomes
Ease of parental separation using PSAS
Time frame: 6 months
Incidence of hypotension and bradycardia in the two groups
Time frame: 6 months
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 18 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intranasal dexmedetomidine and Intranasal ketamine in people with Sedation and Preoperative Anxiety Experienced by the Pediatric Patient, run by Liaquat National Hospital & Medical College.
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 6 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: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Sedation score as assessed by MOAA/S (time frame: 6 months). 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 18 Sep 2025.