| CTRI Number |
CTRI/2018/04/013062 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of oral dexmedetomidine
and oral midazolam as premedicants in children |
|
Scientific Title of Study
|
Comparison between oral dexmedetomidine
and oral midazolam as premedicant in children undergoing herniotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jumaila M |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9496809550 |
| Fax |
|
| Email |
jumiahmed@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Taznim Mohamed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9895012092 |
| Fax |
|
| Email |
taznimashraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Taznim Mohamed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9895012092 |
| Fax |
|
| Email |
taznimashraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Kozhikode, Kerala, India. PIN- 673008 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Kozhikode |
| Address |
Government Medical College, Kozhikode, Kerala-673008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Jumaila M |
Government Medical College. Kozhikode |
Department of Anaesthesiology, Government Medical College. Kozhikode, Kerala
PIN- 673008
Kozhikode
KERALA |
9496809550
jumiahmed@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Medical College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children undergoing herniotomy aged 1-6 years, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral dexmedetomidine 4 µ/kg |
Dexmedetomidine 4 µ/kg administered orally 40 min prior to induction in children undergoing elective herniotomy.
Duration of therapy- Single dose administered 40 minutes prior to induction of anaesthesia. Patient is monitored throughout the surgical procedure and postoperatively till discharge from recovery room |
| Comparator Agent |
Oral midazolam 0.5 mg/kg |
Midazolam 0.5 mg/kg administered orally 40 minutes prior to induction in children undergoing elective herniotomy.
Duration of therapy- Single dose administered 40 minutes prior to induction of anaesthesia. patient is monitored throughout the surgical procedure and till discharge from the recovery room |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Belonging to the American Society of Anesthesiologist physical status Ι
Posted for elective herniotomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with a known allergy to the study drugs
Mental retardation
Neurobehavioral problems |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of sedation, parental separation anxiety, IV acceptability |
Before induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nurse satisfaction, emergence delirium |
After surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/03/2016 |
| Date of Study Completion (India) |
28/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1.Keles S, Kocaturk O. The Effect of Oral Dexmedetomidine Premedication on
Preoperative Cooperation and Emergence Delirium in Children Undergoing Dental
Procedures. Biomed Res Int. 2017;2017:6742183
2.Feng JF, Wang XX, Lu YY, Pang DG, Peng W, Mo JL. Effects of dexmedetomidine
versus midazolam for premedication in paediatric anaesthesia with sevoflurane: A
meta-analysis. J Int Med Res. 2017 Jun;45(3):912-923
3.Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine,
Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients
Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background and Aims: Midazolam has been the most popular premedicant in children despite its side effects. Dexmedetomidine with its favourable clinical profile is a suitable alternative, but with limited research. The aim of this study was to compare the effectiveness of dexmedetomidine and midazolam as oral premedicants in children Materials and methods: 80 children of ASA PS I scheduled for elective herniotomy were included in this prospective randomized observational study. Patients were randomly assigned to receive either dexmedetomidine 4microgram/ kg or midazolam 0.5mg/kg orally 40min prior to induction. Preoperative sedation, response to parental separation and venepuncture, emergence agitation, recovery nurse satisfaction and side effects were compared between the two groups. quantitative data were compared using the unpaired Student"s t- test and categorical variables with Chi-square test Results: Pre-operative sedation, response to parental separation and venepuncture were similar among the two groups. The dexmedetomidine grouo had a significantly lower incidence and severity of emergence agitation. Recovery nurse satisfaction was also higher in the dexmedetomidine group. However, incidence of bradycardia and hypotension was more. Conclusion: Premedication with oral dexmedetomidine is as effective as oral midazolam and produces lesser emergence agitation, though side effects like hypotension and bradycardia may occur
|