| CTRI Number |
CTRI/2022/02/040637 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
23/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sedation of children prior to the surgery using nebulization of two doses of a same drug called dexmedetomidine to reduce parental separation anxiety. |
|
Scientific Title of Study
|
THE EFFECT OF TWO DOSES OF NEBULISED DEXMEDETOMIDINE FOR PREMEDICATION OF PEDIATRIC PATIENTS-A RANDOMISED STUDY |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Mazumder |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College |
| Address |
Gauhati medical college
Department of Anaesthesiology and Critical Care
Bhangagarh
Kamrup
ASSAM
781032
India |
| Phone |
9613960791 |
| Fax |
|
| Email |
sushmitamazumder68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanchita Sarma Borkataki |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College |
| Address |
Gauhati Medical College Bhangagarh
Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchita Sarma Borkataki |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College |
| Address |
Gauhati Medical College Bhangagarh
Guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Gauhati Medical College |
| Address |
Bhangagarh Guwahati Assam |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Mazumder |
Gauhati Medical College |
Department of
Anaesthesiology and
Critical Care,
Pediatrics surgery OT,
ENT OT,
Urology OT,
Bhangagarh Guwahati
Assam
Kamrup
ASSAM
Kamrup
ASSAM |
9613960791
sushmitamazumder68@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Gauhati Medical College And Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q321||Other congenital malformations oftrachea, (2) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (3) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, (4) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, (5) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, (6) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (7) ICD-10 Condition: H260||Infantile and juvenile cataract, (8) ICD-10 Condition: H905||Unspecified sensorineural hearingloss, (9) ICD-10 Condition: K638||Other specified diseases of intestine, (10) ICD-10 Condition: C692||Malignant neoplasm of retina, (11) ICD-10 Condition: G839||Paralytic syndrome, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A - 39 patients, 2 microgram/kg of dexmedetomidine mixed in normal saline to a total volume of 3 ml. |
Group A will receive nebulisation with dexmedetomidine at a dose 3mcg/kg diluted with 0.9% normal saline to a total volume of 3 ml with a nebuliser face mask and a
continuous flow of 100% oxygen at 6 L/min for 10 min once before induction of anaesthesia in sitting position. |
| Intervention |
Group B - 39 patients, 3 microgram/kg dexmedetomidine mixed in normal saline to make a total volume of 3 ml. |
Group B will receive nebulisation with dexmedetomidine at a dose 3mcg/kg diluted with 0.9% normal saline to a total volume of 3 ml with a nebuliser face mask and a
continuous flow of 100% oxygen at 6 L/min for 10 min once before induction of anaesthesia in sitting position. |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 1-8 years.
2.American Society of Anaesthesiologists physical status 1 or 2
3.Availability of informed consent.
4.Any gender
|
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| ExclusionCriteria |
| Details |
1. Parents refusal.
2.Patients with history of cardiac disease,asthma,seizure disorders.
3.patients with mental retardation,developmental delay or any congenital anomalies.
4.Patients with known allergy to dexmedetomidine.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Parental seperation anxiety score and mask acceptance score |
30 mins after beginning of nebulisation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To access hemodynamic variables intraoperatively.
|
10 minutes interval introperatively |
| To access emergence agitation post operatively. |
Immediately after emergence |
| To access post operative sedation. |
1 hour and 2 hours post operatively. |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Preoperative anxiety is seen in 50%-70% of the pediatric patients posted for surgery1.Fear of parent separation,fear of strange hospital environment and painful procedures contribute to preoperative anxiety2.Children with high preoperative anxiety have high incidence of postoperative pain,emergence delirium, delayed discharge and maladaptive and behavioural changes that can last for weeks in postoperative period3.Various drugs have been advocated as premedication to allay anxiety,reduce fear of parental separation and facilitate smooth induction of anesthesia.To date,there is no widely accepted standard regimen or an ideal route of administration for premedication .The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects.Inhalation of nebulised drug is an easy alternative for preoperative sedation as it avoids needle puncture.However, systemic absorption of the nebulised drug depends on multiple factors,such as dosage of the drug,properties of the drug and nebulizer used.Other drugs such as midazolam , ketamine have been tried via oral,nasal and parenteral routes, but each one has its own limitations4.
Dexmedetomidine ,a selective alpha-2 agonist with central sedative and anxiolytic,has been tried as preoperative anxiolytic via nasal and inhalational routes in pediatric patients.Dexmedetomidine nebulisation is an attractive option as pediatric premedication.However,the effective dose is not well established in pediatric patients.So in our study,we want to compare the doses of 2 mcg/kg and 3mcg/kg and study their effects.The null hypothesis of our study is that there is no difference in parental separation and mask acceptance in patients when 2mcg/kg or 3 mcg/kg dexmedetomidine is used as premedication. References :
1.Anupriya J, Kurhekar P. Randomised Comparison between the Efficacy of Two Doses of Nebulised Dexmedetomidine for Premedication in Paediatric Patients. Turk J Anaesthesiol Reanim. 2020 Aug;48(4):314-320. doi: 10.5152/TJAR.2019.78889. Epub 2019 Oct 17. PMID: 32864647; PMCID: PMC7434347.
2.Tan L, Meakin GH. Anaesthesia for uncooperative child. Continuing Education in Anaesthesia Crit Care Pain. 2010;10:48–52. doi: 10.1093/bjaceaccp/mkq003.
3.Fortier MA, Kain ZN. Treating perioperative anxiety and pain in children: A tailored and innovative approach. Paediatr Anaesth. 2015;25:27–35. doi: 10.1111/pan.12546.
4.Sullivan MO, Wong GK. Preinduction techniques to relieve anxiety in children undergoing general anaesthesia. Continuing Education in Anaesthesia Crit Care Pain. 2013;13:196–9. doi: 10.1093/bjaceaccp/mkt014.
5.Zanaty 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):167-71. doi: 10.1213/ANE.0000000000000728. PMID: 25822924
6. Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz HM, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012;67(11):1210–6.
7.WeldonBC,Watcha MF,White PF.Oral midazolamin children:effect of time ad adjunctive therapy.Anesth Analg 1992;75:51-5
8..Akin A,Bayram A, Esmaoglu A,Tosun Z,Aksu R,Altuntas R,et al.Dexmedetomidine vs midazolam for premedication of pediatric patients undergoing anesthsia.Paediatr Anaesth 2012;22:871-6
9.Macnab AJ, Levine M, Glick N,Susak L,Baker-Brown G.A reasearch tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale. J Pediatr Surg1991;26:1263-7
10. Büttner W, Finke w. Analysis of behavioural and physiological parameters for the assessment of postoperative analgesic demand in newborns,infants and young children: a comprehensive report on seven consecutive studies.Paediatric Anaesth 2000;10:303-18
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