AgitationNCT04266340
Different Premedication in Pediatric Patients
A study testing dexmedetomidine, midazolam and Saline in people with Agitation, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Agitation
- What is being tested?
- dexmedetomidine, midazolam and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2020to 1 Dec 2021
- Phase
- Interventional
- 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
- -
Who cannot join
- a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations
The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.
Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. 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 Anesthe-sia Emergence Delirium [PAED] scale) and POV were 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
- Agitation
- Being tested
- dexmedetomidine, midazolam, Saline
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
2.5µg/kg intranasal dexmedetomidine group
midazolamDrug
0.5mg/kg oral midazolam
midazolamDrug
0.05mg/kg intravenous injection midazolam
SalineDrug
no premedication
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | no premedication Receives: Drug: Saline |
| oralmidazolam | Experimental | 0.5 mg/kg oral midazolam group Receives: Drug: midazolam |
| intravenous midazolam | Experimental | 0.05 mg/kg intravenous injection midazolam group Receives: Drug: midazolam |
| dexmedetomidine | Experimental | 2.5µg/kg intranasal dexmedetomidine group Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation
- Rarely awake, needs shaking or shouting to wake up
- Asleep, eyes closed, wakes up when called softly or lightly touched
- Sleepy but eyes open spontaneously
- Awake
- Agitated
Measured: 10 minutes after premedication
Sedation
- Rarely awake, needs shaking or shouting to wake up
- Asleep, eyes closed, wakes up when called softly or lightly touched
- Sleepy but eyes open spontaneously
- Awake
- Agitated
Measured: 20 minutes after premedication
Sedation
- Rarely awake, needs shaking or shouting to wake up
- Asleep, eyes closed, wakes up when called softly or lightly touched
- Sleepy but eyes open spontaneously
- Awake
- Agitated
Measured: 30 minutes after premedication
Emotional state
- Calm
- Apprehensive, not smiling, tentative behaviour, withdrawn
- Crying
- Thrashing, crying with movement of arms and legs, resisting
Measured: 0 minutes after they were separated from their parents
Emotional state
- Calm
- Apprehensive, not smiling, tentative behaviour, withdrawn
- Crying
- Thrashing, crying with movement of arms and legs, resisting
Measured: 0 minutes after intravenous cannulation
Emotional state
- Calm
- Apprehensive, not smiling, tentative behaviour, withdrawn
- Crying
- Thrashing, crying with movement of arms and legs, resisting
Measured: 0 minutes after facemask application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start13 Dec 2020
- Primary completion15 Nov 2021
- Study completion1 Dec 2021
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 AgitationStudies 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 N/A
- Primary purpose
- Prevention
- 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266340
- Sponsor's protocol ID
- 20180341
- Status last verified
- May 2022
- First submitted
- 13 Jan 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qiao H, Chen J, Lv P, Ye Z, Lu Y, Li W, Jia J. Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial. Transl Pediatr. 2022 Nov;11(11):1751-1758. doi: 10.21037/tp-22-161.
PubMed 36506775
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations
- ClinicalTrials.gov ID
- NCT04266340
- Acronym / sponsor ID
- 20180341
- Conditions
- Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Feb 2020 (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 investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.
Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. 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 Anesthe-sia Emergence Delirium [PAED] scale) and POV were 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Salineno premedication |
| oralmidazolam | Experimental | Drug: midazolam0.5 mg/kg oral midazolam group |
| intravenous midazolam | Experimental | Drug: midazolam0.05 mg/kg intravenous injection midazolam group |
| dexmedetomidine | Experimental | Drug: dexmedetomidine2.5µg/kg intranasal dexmedetomidine group |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.
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 |
|---|---|---|
| dexmedetomidine2.5µg/kg intranasal dexmedetomidine group | Drug | dexmedetomidine |
| midazolam0.5mg/kg oral midazolam | Drug | oralmidazolam |
| midazolam0.05mg/kg intravenous injection midazolam | Drug | intravenous midazolam |
| Salineno premedication | Drug | placebo |
Primary outcome
Sedation
Time frame: 10 minutes after premedication
1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated
Sedation
Time frame: 20 minutes after premedication
1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated
Sedation
Time frame: 30 minutes after premedication
1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated
Emotional state
Time frame: 0 minutes after they were separated from their parents
1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting
Emotional state
Time frame: 0 minutes after intravenous cannulation
1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting
Emotional state
Time frame: 0 minutes after facemask application
1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting
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 11 May 2022.
- Derived from this study: PubMed 36506775Qiao H, Chen J, Lv P, Ye Z, Lu Y, Li W, Jia J. Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial. Transl Pediatr. 2022 Nov;11(11):1751-1758. doi: 10.21037/tp-22-161.
- 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. 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 study testing dexmedetomidine, midazolam and Saline in people with Agitation, 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 11 May 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.
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?
Sedation (time frame: 10 minutes after premedication). The study lists 6 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 NCT04266340, 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 11 May 2022.