SedationNCT04820205
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
A study testing Intranasal dexmedetomidine and ketamine and Oral chloral hydrate in people with Sedation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the first-attempt success rate of pediatric procedural sedation. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation
- What is being tested?
- Intranasal dexmedetomidine and ketamine and Oral chloral hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Oct 2021to 5 Mar 2024
- Phase
- Interventional
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 Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients who need procedural sedation (Age < 7 years)
- ASA (American Society of Anesthesiologists) physical status 1-3
Who cannot join
- ASA (American Society of Anesthesiologists) physical status 4-5
- History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
- Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
- Cannot administrate oral medication (e.g. Swallowing difficulty)
- Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
- Unstable vital signs, Unstable arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial
In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients undergoing procedural sedation. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).
- Conditions
- Sedation
- Being tested
- Intranasal dexmedetomidine and ketamine, Oral chloral hydrate
- Keywords
- pediatric, procedural sedation, chloral hydrate, intranasal dexmedetomidine, intranasal ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidine and ketamineDrug
Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
Oral chloral hydrateDrug
Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
| Study group | Role | What they receive |
|---|---|---|
| intranasal dexmedetomdine and kemtaine | Experimental | Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) Receives: Drug: Intranasal dexmedetomidine and ketamine |
| oral chloral hydrate | Active comparator | Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3) Receives: Drug: Oral chloral hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes %
Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %
Measured: During pediatric procedural sedation (up to 1 hour)
Secondary outcomes (21)
Onset time of sedation (PSSS= 0,1,2,3) (min)
Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.
Measured: During pediatric procedural sedation (up to 3 hour)
Duration of sedation = Recovery time (PSSS= 4,5) (min)
Pediatric Sedation State Scale= 4,5 after recovery of sedation
Measured: During pediatric procedural sedation (up to 3 hour)
PSSS(Pediatric Sedation State Scale, 0-5)
5 Patient is moving in a manner that impedes the proceduralist and requires forceful immobilization.
4 Moving during the procedure that requires gentle immobilization for positioning.
3 Expression of pain or anxiety on face, but not moving or impeding completion of the procedure.
2 Quiet (asleep or awake), not moving during procedure, and no frown (or brow furrow) indicating pain or anxiety.
1 Deeply asleep with normal vital signs, but requiring airway intervention and/or assistance 0 Sedation associated with abnormal physiologic parameters that require acute intervention q 10min
Measured: During pediatric procedural sedation (up to 3 hour)
Heart rate during sedation (/min)
HR(/min) at Baseline(T0), q 10min
Measured: During pediatric procedural sedation (up to 3 hour)
SpO2 during sedation (%)
SpO2(%) by pulse oximetry at Baseline(T0), q 10min
Measured: During pediatric procedural sedation (up to 3 hour)
Respiratory rate during sedation (/min)
RR(/min) at Baseline(T0), q 10min
Measured: During pediatric procedural sedation (up to 3 hour)
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of respiratory intervention: Manual ventilation or Artificial airway %
The incidence of respiratory intervention: Manual ventilation or Artificial airway
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %
The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of significant apnea (>20seconds) %
The incidence of significant apnea (>20seconds) %
Measured: During pediatric procedural sedation (up to 3 hour)
The lowest SpO2 value (%)
The lowest SpO2 value (%)
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of hemodynamic intervention: fluid management, intravenous medication %
The incidence of hemodynamic intervention: fluid management, intravenous medication %
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of significant bradycardia (-30% from baseline) %
The incidence of significant bradycardia (-30% from baseline) %
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of significant hypotension (-30% from baseline) %
The incidence of significant hypotension (-30% from baseline) %
Measured: During pediatric procedural sedation (up to 3 hour)
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)
Measured: During pediatric procedural sedation (up to 3 hour)
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)
Measured: During pediatric procedural sedation (up to 3 hour)
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min %
Failure of adequate sedation (PSSS= 0, 4,5) after 30 min %
Measured: During pediatric procedural sedation (up to 3 hour)
The incidence of completion of procedure
Completion of procedure
Measured: During pediatric procedural sedation (up to 3 hour)
Total cost of sedation (KRW), optional
Total cost of sedation (KRW), if applicable
Measured: During pediatric procedural sedation (up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start29 Oct 2021
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820205
- Sponsor's protocol ID
- IN DEXKET first
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang 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 26714442Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.
PubMed 28414899Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
PubMed 24237879Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
PubMed 25822924Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.
PubMed 27627818Jun JH, Kim KN, Kim JY, Song SM. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21.
PubMed 28639236Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22.
PubMed 30032884Poonai N, Canton K, Ali S, Hendrikx S, Shah A, Miller M, Joubert G, Rieder M, Hartling L. Intranasal ketamine for procedural sedation and analgesia in children: A systematic review. PLoS One. 2017 Mar 20;12(3):e0173253. doi: 10.1371/journal.pone.0173253. eCollection 2017.
PubMed 28319161Jang YE, Joo EY, Lee JH, Kim EH, Kang P, Park JB, Kim HS, Kim JT. Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol. Trials. 2023 Jan 3;24(1):2. doi: 10.1186/s13063-022-07033-x.
PubMed 36597163