Preoperative Sedation of ChildrenPhase 3NCT05111431
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
A Phase 3 study testing Dexmedetomidine Hydrochloride Nasal Spray and Dexmedetomidine hydrochloride nasal spray blank preparation in people with Preoperative Sedation of Children, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Preoperative Sedation of Children
- What is being tested?
- Dexmedetomidine Hydrochloride Nasal Spray and Dexmedetomidine hydrochloride nasal spray blank preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2021to 20 May 2022
- Phase
- Phase 3
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able and willing to provide a written informed consent
- Male or female
- Subjects requiring elective general anesthesia surgery
- Conform to the ASA Physical Status Classification
- Meet the weight standard
Who cannot join
- Not suitable for nasal spray
- Pediatric populations requiring special care or court/social welfare supervision
- Subjects who had been under general anesthesia when they were randomized
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with cardiovascular disease
- Subjects whose hemoglobin is below the lower limit of normal
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- Subjects with a history or possibility of a difficult airway
- Abnormal liver function and/or abnormal renal function
- Adrenoceptor agonists or antagonists or analgesics were used before randomization
- Participated in clinical trials (received experimental drugs)
- History of hypersensitivity to drug ingredients or components
- Other circumstances that the investigator judged inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100045
About this study
Official title: Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
- Conditions
- Preoperative Sedation of Children
- Being tested
- Dexmedetomidine Hydrochloride Nasal Spray, Dexmedetomidine hydrochloride nasal spray blank preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride Nasal SprayDrug
In the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray.
In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray.
Dexmedetomidine hydrochloride nasal spray blank preparationDrug
In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Hydrochloride Nasal Spray | Experimental | Not described Receives: Drug: Dexmedetomidine Hydrochloride Nasal Spray |
| Dexmedetomidine hydrochloride nasal spray blank preparation | Placebo comparator | Not described Receives: Drug: Dexmedetomidine hydrochloride nasal spray blank preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who meet parent-child separation successful
Measured: within 45 minutes after the beginning of administration
Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration
Measured: within 45 minutes after the beginning of administration
Secondary outcomes (7)
Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration
The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item.
Measured: Within 45 minutes after the beginning of administration
Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days
The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item.
Measured: an average of 3 days
Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration
Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.
Measured: Within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory Ramsay score for the first time
Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.
Measured: from the beginning of administration to the first successful Ramsay score
Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration
Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2 .
Measured: within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days
Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2.
Measured: an average of 3 days
Time of anesthesia awakening through study completion，an average of 3 days
Measured: an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start24 Nov 2021
- Primary completion20 May 2022
- Study completion20 May 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 Preoperative Sedation of ChildrenStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexmedetomidine hydrochloride nasal spray compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111431
- Sponsor's protocol ID
- HR0171401-302
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.
PubMed 39242499
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
- ClinicalTrials.gov ID
- NCT05111431
- Acronym / sponsor ID
- HR0171401-302
- Conditions
- Preoperative Sedation of Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 8 Nov 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.
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dexmedetomidine hydrochloride nasal spray compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Hydrochloride Nasal Spray | Experimental | Drug: Dexmedetomidine Hydrochloride Nasal Spray |
| Dexmedetomidine hydrochloride nasal spray blank preparation | Placebo comparator | Drug: Dexmedetomidine hydrochloride nasal spray blank preparation |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Male or female
- Subjects requiring elective general anesthesia surgery
- Conform to the ASA Physical Status Classification
- Meet the weight standard
Key exclusion criteria (12 listed)
- Not suitable for nasal spray
- Pediatric populations requiring special care or court/social welfare supervision
- Subjects who had been under general anesthesia when they were randomized
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with cardiovascular 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 |
|---|---|---|
| Dexmedetomidine Hydrochloride Nasal SprayIn the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray. | Drug | Dexmedetomidine Hydrochloride Nasal Spray |
| Dexmedetomidine hydrochloride nasal spray blank preparationIn the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. | Drug | Dexmedetomidine hydrochloride nasal spray blank preparation |
Primary outcome
Proportion of subjects who meet parent-child separation successful
Time frame: within 45 minutes after the beginning of administration
Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration
Time frame: within 45 minutes after the beginning of administration
7 secondary outcomes
Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration
Time frame: Within 45 minutes after the beginning of administration
Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days
Time frame: an average of 3 days
Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration
Time frame: Within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory Ramsay score for the first time
Time frame: from the beginning of administration to the first successful Ramsay score
Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration
Time frame: within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days
Time frame: an average of 3 days
Time of anesthesia awakening through study completion，an average of 3 days
Time frame: an average of 3 days
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 7 Nov 2022.
- Derived from this study: PubMed 39242499Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1.
- Individual participant dataSharing planned: Undecided
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The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Preoperative Sedation
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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.
Sedation, Preoperative Anxiety Experienced by the Pediatric Patient
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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 Phase 3 study testing Dexmedetomidine Hydrochloride Nasal Spray and Dexmedetomidine hydrochloride nasal spray blank preparation in people with Preoperative Sedation of Children, run by Shanghai Hengrui Pharmaceutical Co., Ltd. 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 5 inclusion and 12 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 7 Nov 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects who meet parent-child separation successful (time frame: within 45 minutes after the beginning of administration). The study lists 2 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 NCT05111431, 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 7 Nov 2022.