Administration Related ReactionPhase 4NCT02239445
Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
A Phase 4 study testing chloral hydrate Group, low dose dexmedetomidine group and high dose dexmedetomidine group in people with Administration Related Reaction and Failed Moderate Sedation During Procedure, run by Guangzhou Women and Children's Medical Center at 2 sites in China.
Trial summary
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate. Read more about this study
- Who is it for?
- Ages 1 month to 6 months
- Conditions the study is for
- Administration Related Reaction, Failed Moderate Sedation During Procedure, Chloral Hydrate Adverse Reaction
- What is being tested?
- chloral hydrate Group, low dose dexmedetomidine group and high dose dexmedetomidine group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 4
- 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 1 month to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
Who cannot join
- known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Anesthesiology of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
About this study
The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.
- Conditions
- Administration Related Reaction, Failed Moderate Sedation During Procedure, Chloral Hydrate Adverse Reaction
- Being tested
- chloral hydrate Group, low dose dexmedetomidine group, high dose dexmedetomidine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloral hydrate GroupDrug
chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
low dose dexmedetomidine groupDrug
Also called AiBeiNing
Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
high dose dexmedetomidine groupDrug
Also called AiBeiNing
Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
| Study group | Role | What they receive |
|---|---|---|
| chloral hydrate group | Active comparator | chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline) Receives: Drug: chloral hydrate Group |
| low dose dexmedetomidine Group | Experimental | Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. Receives: Drug: low dose dexmedetomidine group |
| high dose dexmedetomidine group | Experimental | Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. Receives: Drug: high dose dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful rescue sedation rate
Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1).
successful sedation was defined as an MOAA/S of between 0 and 3
Measured: up to 1 hours after MRI scaning
Secondary outcomes (2)
sedation induction time
Successful sedation was defined as an MOAA/S of between 0 and 2, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation
0 Does not respond to a noxious stimulus
- Does not respond to mild prodding or shaking
- Responds only after mild prodding or shaking
- Responds only after name is called loudly orrepeatedly
- Lethargic response to name spoken in normal tone
- Appears asleep, but responds readily to namespoken in normal tone
- Appears alert and awake, responds readily to namespoken in normal tone
Measured: up to 30 min after rescue drug administration
Wake -up time
Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke
Measured: up to 4 hours after rescue drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Administration Related ReactionStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhua Zhang, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239445
- Sponsor's protocol ID
- WZhang
- Status last verified
- May 2015
- First submitted
- 4 Sep 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
PubMed 34397100Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
PubMed 26714442Miller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30.
PubMed 26616644
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02239445
- Acronym / sponsor ID
- WZhang
- Conditions
- Administration Related Reaction, Failed Moderate Sedation During Procedure, Chloral Hydrate Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Sep 2014 (estimated)
- 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 purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chloral hydrate group | Active comparator | Drug: chloral hydrate Groupchloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline) |
| low dose dexmedetomidine Group | Experimental | Drug: low dose dexmedetomidine groupGroup L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. |
| high dose dexmedetomidine group | Experimental | Drug: high dose dexmedetomidine groupGroup H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning
Key exclusion criteria (1 listed)
- known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart 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 |
|---|---|---|
| chloral hydrate Groupchloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline) | Drug | chloral hydrate group |
| low dose dexmedetomidine groupAlso: AiBeiNingGroup L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup | Drug | low dose dexmedetomidine Group |
| high dose dexmedetomidine groupAlso: AiBeiNingGroup H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup | Drug | high dose dexmedetomidine group |
Primary outcome
successful rescue sedation rate
Time frame: up to 1 hours after MRI scaning
Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1). successful sedation was defined as an MOAA/S of between 0 and 3
2 secondary outcomes
sedation induction time
Time frame: up to 30 min after rescue drug administration
Wake -up time
Time frame: up to 4 hours after rescue drug administration
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 12 May 2015.
- Derived from this study: PubMed 34397100Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
- Derived from this study: PubMed 26714442Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
- Derived from this study: PubMed 26616644Miller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chloral hydrate Group, low dose dexmedetomidine group and high dose dexmedetomidine group in people with Administration Related Reaction and Failed Moderate Sedation During Procedure, run by Guangzhou Women and Children's Medical Center at 2 sites 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
successful rescue sedation rate (time frame: up to 1 hours after MRI scaning). 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 NCT02239445, which also lists 3 linked publications.
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 12 May 2015.