An Early Phase 1 interventional study of S-ketamine 0.3 and S-ketamine 0.5 in Emotions, Separation Anxiety and Pain, Procedural, sponsored by Eye & ENT Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Eye & ENT Hospital of Fudan University · Early Phase 1, Interventional, and Treatment
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.
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.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 320 is above the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.3 μg/kg intravenous injection s-ketamin
Drug: S-ketamine 0.3
0.5 μg/kg intravenous injection s-ketamin
Drug: S-ketamine 0.5
2 μg/kg intranasal s-ketamin
Drug: S-ketamine 2
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
Drug: S-ketamine 1+Dexmedetomidine 1
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Drug: S-ketamine 0.5 +Dexmedetomidine 2
0.3 μg/kg intravenous injection s-ketamin
Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intravenous injection s-ketamin
Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
2 μg/kg intranasal s-ketamin
Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 1 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 5 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 10 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 20 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 30 min after premedication
Parental Separation Anxiety Scale (PSAS)
1. = easy separation 2. = whimpers, but is easily reassured, not clinging 3. = cries and cannot be easily reassured, but not clinging to parents 4. = crying and clinging to parents
Time frame: 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.
Time frame: 15 min after premedication
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eye & ENT Hospital of Fudan University →