EmotionsEarly Phase 1NCT04757675
S-ketamin Premedication in Pediatric EENT Surgery
A Early Phase 1 study testing S-ketamine 0.3, S-ketamine 0.5 and S-ketamine 2 in people with Emotions and Separation Anxiety, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Emotions, Separation Anxiety, Pain, Procedural
- What is being tested?
- S-ketamine 0.3, S-ketamine 0.5 and S-ketamine 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Jan 2022
- Phase
- Early 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study.
Who cannot join
- Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery
We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.
Read the detailed description
Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group.
The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia Emergence Delirium [PAED] scale) and POV was assessed in the postanesthetic care unit (PACU). Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and patients' satisfaction degree were also assessed.
- Conditions
- Emotions, Separation Anxiety, Pain, Procedural
- Being tested
- S-ketamine 0.3, S-ketamine 0.5, S-ketamine 2, S-ketamine 1+Dexmedetomidine 1, S-ketamine 0.5 +Dexmedetomidine 2
- Medical subject headings
- Anxiety, Separation, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamine 0.3Drug
Also called Jiangsu Hengrui Medicine Co.,Ltd.
0.3 μg/kg intravenous injection s-ketamin
S-ketamine 0.5Drug
Also called Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intravenous injection s-ketamin
S-ketamine 2Drug
Also called Jiangsu Hengrui Medicine Co.,Ltd.
2 μg/kg intranasal s-ketamin
S-ketamine 1+Dexmedetomidine 1Drug
Also called Jiangsu Hengrui Medicine Co.,Ltd.
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
S-ketamine 0.5 +Dexmedetomidine 2Drug
Also called Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| 0.3 SK iv | Experimental | 0.3 μg/kg intravenous injection s-ketamin Receives: Drug: S-ketamine 0.3 |
| 0.5 SK iv | Experimental | 0.5 μg/kg intravenous injection s-ketamin Receives: Drug: S-ketamine 0.5 |
| 2 SK in | Experimental | 2 μg/kg intranasal s-ketamin Receives: Drug: S-ketamine 2 |
| 1 SK in + 1 DEX in | Experimental | 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine Receives: Drug: S-ketamine 1+Dexmedetomidine 1 |
| 0.5 SK in + 2 DEX in | Experimental | 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine Receives: Drug: S-ketamine 0.5 +Dexmedetomidine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Measured: 1 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Measured: 5 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Measured: 10 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Measured: 20 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Measured: 30 min after premedication
Secondary outcomes (2)
Parental Separation Anxiety Scale (PSAS)
- = easy separation
- = whimpers, but is easily reassured, not clinging
- = cries and cannot be easily reassured, but not clinging to parents
- = crying and clinging to parents
Measured: 30 min after premedication
Emotional State Scale
Successful venous cannulation was defined as an ESS-4 ≤2 at the time of attempted cannulation, regardless of whether the vein was actually cannulated on the first attempt.
Measured: 15 min after premedication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmotionsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Qiao, Eye & ENT Hospital of Fudan University
- Investigators
- Hui Qiao, M.D., Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757675
- Sponsor's protocol ID
- Premedication s-ketamin
- Status last verified
- Apr 2022
- First submitted
- 13 Feb 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiao H, Zhuang Y, Lv P, Ye Z, Lu Y, Jia J. Intranasal esketamine versus esketamine-dexmedetomidine combination for premedication in pediatric patients undergoing strabismus surgery: a randomized controlled trial. Transl Pediatr. 2024 Aug 31;13(8):1327-1335. doi: 10.21037/tp-24-45. Epub 2024 Aug 28.
PubMed 39263280
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery
- ClinicalTrials.gov ID
- NCT04757675
- Acronym / sponsor ID
- Premedication s-ketamin
- Conditions
- Emotions, Separation Anxiety, Pain, Procedural
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Feb 2021 (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.
We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.
Detailed description
Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group.
The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia Emergence Delirium [PAED] scale) and POV was assessed in the postanesthetic care unit (PACU). Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and patients' satisfaction degree were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.3 SK iv | Experimental | Drug: S-ketamine 0.30.3 μg/kg intravenous injection s-ketamin |
| 0.5 SK iv | Experimental | Drug: S-ketamine 0.50.5 μg/kg intravenous injection s-ketamin |
| 2 SK in | Experimental | Drug: S-ketamine 22 μg/kg intranasal s-ketamin |
| 1 SK in + 1 DEX in | Experimental | Drug: S-ketamine 1+Dexmedetomidine 11 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine |
| 0.5 SK in + 2 DEX in | Experimental | Drug: S-ketamine 0.5 +Dexmedetomidine 20.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study.
Key exclusion criteria (1 listed)
- Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney 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 |
|---|---|---|
| S-ketamine 0.3Also: Jiangsu Hengrui Medicine Co.,Ltd.0.3 μg/kg intravenous injection s-ketamin | Drug | 0.3 SK iv |
| S-ketamine 0.5Also: Jiangsu Hengrui Medicine Co.,Ltd.0.5 μg/kg intravenous injection s-ketamin | Drug | 0.5 SK iv |
| S-ketamine 2Also: Jiangsu Hengrui Medicine Co.,Ltd.2 μg/kg intranasal s-ketamin | Drug | 2 SK in |
| S-ketamine 1+Dexmedetomidine 1Also: Jiangsu Hengrui Medicine Co.,Ltd.1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine | Drug | 1 SK in + 1 DEX in |
| S-ketamine 0.5 +Dexmedetomidine 2Also: Jiangsu Hengrui Medicine Co.,Ltd.0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine | Drug | 0.5 SK in + 2 DEX in |
Primary outcome
The modified Yale Preoperative Anxiety Scale
Time frame: 1 min after premedication
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
Time frame: 5 min after premedication
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
Time frame: 10 min after premedication
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
Time frame: 20 min after premedication
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
Time frame: 30 min after premedication
A validated observational tool for assessing children's anxiety
2 secondary outcomes
Parental Separation Anxiety Scale (PSAS)
Time frame: 30 min after premedication
Emotional State Scale
Time frame: 15 min after premedication
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 27 Apr 2022.
- Derived from this study: PubMed 39263280Qiao H, Zhuang Y, Lv P, Ye Z, Lu Y, Jia J. Intranasal esketamine versus esketamine-dexmedetomidine combination for premedication in pediatric patients undergoing strabismus surgery: a randomized controlled trial. Transl Pediatr. 2024 Aug 31;13(8):1327-1335. doi: 10.21037/tp-24-45. Epub 2024 Aug 28.
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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.
Hui Qiao, M.D. principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing S-ketamine 0.3, S-ketamine 0.5 and S-ketamine 2 in people with Emotions and Separation Anxiety, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 1 inclusion and 1 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 27 Apr 2022. 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The modified Yale Preoperative Anxiety Scale (time frame: 1 min after premedication). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757675, which also lists 1 linked publication.
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 Apr 2022.