- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02664857
Vitamin D Supplementations and Postoperative Pain
April 20, 2021 updated by: ebru biricik, Cukurova University
Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation
In this study, effect of vitamin D supplementation on postoperative pain and sedation-agitation will investigate.
Children with mental motor retardation between 7-17 age which dental treatment will be performed under general anaesthesia will be included in this study.
600 IU vitamin D will apply to group D per orally during 12 weeks.
Group P will not take anything during 12 weeks.
At first day and end of the 12 weeks, serum vitamin D, calcium level will evaluate.
At the end of the 12 weeks general anaesthesia will be performed for teeth check up, flouring, scaling polishing, tooth extraction, filling applications, amputations, root canal treatment.
After then postoperative pain, sedation and agitation will be evaluate.
All data will be statistically evaluate at the end of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Vitamin D deficiency could seem in children with mental and motor retardation.
Some researches show that vitamin D supplementations can reduce pain.
In this study, the researchers aimed to show effect of vitamin D supplementation on postoperative pain and sedation-agitation.
These children which will be applied dental treatment under general anaesthesia included in this study.
All subjects randomly divided to the two groups.
Every group will include 30 subject.
Group D included mentally retarded children which will take daily 600 IU orally vitamin D supplementation during 12 weeks.
In the other group(group P) mentally retarded children will not take any supplementation during 12 week.
At the first day and last day(after 12 weeks) of study, blood sample will take from all subject.
Serum vitamin D, calcium level will evaluate in this sample at the end of the study.
All samples will be frozen and stored until testing.
All children will be operated under general anaesthesia.
Propofol 2mg/kg, rocuronium 0,6 mg/kg will apply for anaesthesia induction.
Anaesthesia will maintain with sevoflurane and oxygen- nitrous oxide mixture.
Non-communicating Children's Pain Check-list and Ramsey sedation scale will apply all children after postoperative care unit.
All children will be evaluate every 15 minutes.
After data collection, all data will be analysed with statistically.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Adana, Turkey, 01380
- Cukurova University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mentally and motor retarded children
- dental treatment under general anaesthesia
Exclusion Criteria:
- normally children(not MMR)
- The persons who not accept the including study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: vitamin D
After per orally vitamin D supplementation during 12 weeks, serum Vitamin D level will evaluate with laboratory testing.
600 IU vitamin D will apply to 30 subject during 12 weeks.
At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia.
Postoperative pain, anxiety and sedation will evaluate.
|
Group D will take 600 IU vitamin D per orally during 12 weeks.
At first day and end of the 12 weeks serum vitamin D level will analyse with laboratory testing
Other Names:
|
Sham Comparator: Placebo
Grup P will not take vitamin D during 12 weeks.
This group just only will follow by researchers.At first day end end of the 12 weeks serum vitamin D level will analyse with laboratory testing.End of the 12 weeks, the children will be perform dental treatment under general anaesthesia.
Postoperative pain, anxiety and sedation will evaluate.
|
Group P will not take orally during 12 weeks.
This group will only observe by researchers.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-communicating Children's Pain Checklist - Postoperative Version
Time Frame: At Postoperative period for first 1 hour
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The subjects will evaluate per 15 minutes for 1 hour.
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At Postoperative period for first 1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vitamin D level
Time Frame: At first day and end of the 12 weeks
|
Serum vitamin D level will evaluate At first day and end of the 12 weeks.
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At first day and end of the 12 weeks
|
Postoperative sedation-agitation
Time Frame: At postoperative first hour
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At postoperative period, every 15 minutes up to 1 hour.
Ramsey sedation scores will record.
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At postoperative first hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dilek Ozcengiz, Professor, Cokurova University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
January 20, 2016
First Submitted That Met QC Criteria
January 22, 2016
First Posted (Estimate)
January 27, 2016
Study Record Updates
Last Update Posted (Actual)
April 21, 2021
Last Update Submitted That Met QC Criteria
April 20, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vitamin d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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