| CTRI Number |
CTRI/2021/11/038074 [Registered on: 16/11/2021] Trial Registered Prospectively |
| Last Modified On: |
15/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To decrease anxiety in children before shifting to operating room by giving nebulization |
|
Scientific Title of Study
|
Comparison of nebulised dexmedetomedine,ketamine and fentanyl for premedication in children undergoing infraumbilical surgery |
| Trial Acronym |
DKF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aathira das |
| Designation |
junior resident |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Department of anaesthesiology
Rajendra institute of medical sciences, Ranchi
Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9447736160 |
| Fax |
|
| Email |
aathiradas83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali singh |
| Designation |
Additional professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Additional professor
Superspeciality Anesthesia
RIMS Ranchi
Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9620310511 |
| Fax |
|
| Email |
dipalishio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali singh |
| Designation |
Additional professor |
| Affiliation |
Rajendra institute of medical sciences |
| Address |
Additional professor
Superspeciality Anesthesia
RIMS Ranchi
Rajendra institute of medical sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9620310511 |
| Fax |
|
| Email |
dipalishio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences, ranchi |
|
|
Primary Sponsor
|
| Name |
Dr Aathira das |
| Address |
Rajendra institute of medical sciences, Ranchi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Aathira das |
Rajendra institute of medical sciences |
Department of Anaesthesia,2ND FLOOR, Rajendra institute of medical sciences,Ranchi
Ranchi
JHARKHAND |
9447736160
aathiradas83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine, dexmedetomidine, fentanyl |
nebulisation with ketamine 2mg/kg or fentanyl 2mcg/kg or dexmedetomidine 2mcg/kg for 10 min and comparing their effect on sedation ,analgesia, emergence agitation. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. parents consent
2.age group 3-8 yrs
3.type of surgery included:infraumbilical surgery
4.ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Parents refusal
2.All patients who have history of allergies to any of the drugs used in the study.
3.Congenital disease
4 Developmental delay |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of sedation when the child first seen in the OR 30 min after sedation based on Ramsay sedation scale. |
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental seperation ,perioperative HR and BP,hemodynamical changes,sedation at emergence,post operative Face,Legs,Activity,Cry,Consolobility(FLACC) pain scale,the incidence of emergence agitation (EA),adverse events. |
perioperative assessment:0,5,10,20,30 min
intraoperative assessment:0,5,10,15,20min
post operative assessment:0,15,30,45,60min |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2021 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published, yet to start. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized, double-blinded study . This study is designed to evaluate and compare the efficacy and safety of nebulized dexmedetomidine, nebulized ketamine, and nebulized fentanyl as a premedication prior to general anaesthesia (GA) in paediatric patients. All patients who are allergic to the drugs used in this study ,Congenital heart disease,developmental delay and parental refusal are excluded from the study.Study will be done in 3-8 years of age group. Patients will be randomly categorized into 3 equal groups (30 each) using a random numbers table with group allocation concealed in sealed opaque envelopes. Group K patients will be premedicated with nebulized ketamine solution (2 mg/kg), group D patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg), and group F will be premedicated with nebulized fentanyl(2mcg/kg).The observers and attending anaesthesiologists will be blinded to the drug being administered. A researcher who will not participate in the evaluation will administer the drugs to all the children in nebuliser. OUTCOMES: 1) The primary end point is the degree of sedation when the child was first seen in the OR 30 minutes after sedation, based on the Ramsay Sedation Scale.. 2) The secondary end points are parental separation, perioperative HR and BP, hemodynamic changes, sedation at emergence,post operative Face ,Legs ,Activity, Cry ,Consolability (FLACC) pain scale, the incidence of Emergence Agitation (EA),adverse effects. REFERENCES 1. Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004;98:1252–9 2. Hosey MT, Macpherson LM, Adair P, Tochel C, Burnside G, Pine C. Dental anxiety, distress at induction and postoperative morbidity in children undergoing tooth extraction using general anaesthesia. Br Dent J. 2006;200:39–43 3. Hosey MT, Asbury AJ, Bowman AW, Millar K, Martin K, Musiello T, Welbury R. The effect of transmucosal 0.2 mg/kg midazolam premedication on dental anxiety, anaesthetic induction and psychological morbidity in children undergoing general anaesthesia for tooth extraction. Br Dent J. 2009;207:E2 4.Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004;99:1648–54 6. Warrington SE, Kuhn RJ. Use of intranasal medications in pediatric patients. Orthopedics. 2011;34:456–9 |