CTRI Number |
CTRI/2014/01/004335 [Registered on: 22/01/2014] Trial Registered Retrospectively |
Last Modified On: |
12/03/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Oral midazolam or intranasal dexmedetomidine in paediatric dental treatment |
Scientific Title of Study
|
A comparison of oral midazolam with intranasal dexmedetomidine in paediatric patients requiring restorative dental treatment |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
MS/1318/8108 vesion 1 dated 22.09.2012 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Abhishek Jha |
Designation |
Junior Resident |
Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh CHANDIGARH 160012 India |
Phone |
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Fax |
|
Email |
netizen_18@rediffmail.com |
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Details of Contact Person Scientific Query
|
Name |
Dr Babita Ghai |
Designation |
Additional Professor |
Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh CHANDIGARH 160012 India |
Phone |
9914209533 |
Fax |
|
Email |
ghaibabita@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Babita Ghai |
Designation |
Additional Professor |
Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh CHANDIGARH 160012 India |
Phone |
9914209533 |
Fax |
|
Email |
ghaibabita@hotmail.com |
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Source of Monetary or Material Support
|
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Primary Sponsor
|
Name |
Post Graduate Institute of Medical Education and Research |
Address |
4th Floor, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh-160012, India |
Type of Sponsor |
Research institution and hospital |
|
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 Babita Ghai |
Department of oral health |
Post Graduate Institute of Medical Education and Research, Chandigarh Chandigarh CHANDIGARH |
9914209533
ghaibabita@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Review Committee, Postgraduate Institute of Medical Education And Research, Sector 12, Chandigarh-160012 |
Approved |
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intranasal Dexmedetomidine |
intranasal Dexmedetomidine 2.5mcg/kg along with oral plain honey was administered 25-30 minutes before start of dental procedure |
Comparator Agent |
Oral midazolam |
oral midazolam (0.5mg/kg) mixed in 5 ml of honey was administered along with intranasal saline 25-30 minutes before start of dental procedure |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
6.00 Year(s) |
Gender |
Both |
Details |
uncooperative children aged 2-6years who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration |
|
ExclusionCriteria |
Details |
Patients with previous exposure to dental sedation, neurodevelopmental anomalies, abnormal cardiac anatomy, Craniofacial anatomical defects , allergy to EMLA cream, allergy to study drugs
|
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Dose of ketamine required to keep acceptable Houpts scores for procedure |
during the 20-30 minutes of proceudre |
|
Secondary Outcome
|
Outcome |
TimePoints |
Ramsay sedation Scores, Heart rate, non invasive blood pressure |
Ramsay sedation score-before premedication, and 15 and 30 minutes after premedication, after procedure
heart rate and non invasive blood pressure- at above mentioned times as well as during procedure
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/11/2010 |
Date of Study Completion (India) |
Date Missing |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Sedation is frequently desired in young children
undergoing day-care dental treatments.Conscious sedation is a safe technique
which offers sedation, relief of pain and anxiety with minimal systemic risks.
Midazolam is the conventionally used sedative in a wide variety of applications.
exmedetomidine is a newer alpha-2 agonist which provides sedation, analgesia
and anxiolysis and has been used intravenously for pediatric procedural
sedation in a variety of settings such as radiological imaging (MRI, CT Scan),
awake craniotomies and cardiac catheterization.We planned this study to compare
the efficacy of intranasal Dexmedetomidine with oral Midazolam for sedation in
uncooperative children undergoing restorative dental procedures between 2-6
years of age. After institutional ethics committee approval, and written
informed consent from parents, uncooperative children aged 2-6years were
selected from the outpatient department of Oral Health Centre of our Institute.
Only those children who were scheduled for restorative procedures (RCT, tooth extractions,
fillings etc.) of less than 45mins of duration were enrolled for the study.
Children were randomly assigned to two groups for premedication using
computer-generated random number chart 20 mins after EMLA cream application.
Group D received intranasal Dexmedetomidine 2.5mcg/kg, (half the
total dose loaded in a 2cc syringe undiluted in each nostril) and 5ml oral
honey, as control. Group M received
oral Midazolam 0.5mg/kg mixed with 5 ml honey and sterile water nasal drops (in
a 2cc syringe equal volume in both nostrils) as control.
IV cannulation was
attempted 30 minutes after premedication at the site pre-treated with EMLA
cream. The children were then shifted to the dental chair and the child’s
behavior during dental procedure was assessed using Houpt’s behavior rating
scale of movement. A score of 3 was accepted as favourable. To score the
overall behavior and outcome of treatment The Houpt’s overall behavior rating
scale was used (Appendix 3).The optimum
score which was to be achieved was >3.A score of 5/6 was considered as the best score. IV Ketamine
boluses 0.5mg/kg were given till optimal sedation for the procedure is achieved. The duration of procedure and the
total dose of the Ketamine administered was recorded.Intra-procedural vitals like
HR, ECG, NIBP and Oxygen Saturation were monitored continuously at regular 10
minute intervals.The children were kept in observation area for a period of
60minutes after the end of the procedure. At the end of procedure, the
dentist’s opinion was obtained for the overall experience in performing the
procedure as either Good/Fair/Bad. The children were then discharged according
to the modified Aldrette scoring criteria (Appendix 4). A score of 9/10 was
considered as the sufficient criteria for discharge. The parents were contacted
by making a telephone call in the evening to elicit any untoward effects or
abnormality in the behaviour of their child. A note was made of the same, if
any of these was present.
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