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Vitamin D Supplementations and Postoperative Pain

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ClinicalTrials.gov Identifier: NCT02664857
Recruitment Status : Unknown
Verified March 2017 by ebru biricik, Cukurova University.
Recruitment status was:  Recruiting
First Posted : January 27, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
ebru biricik, Cukurova University

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE January 27, 2016
Last Update Posted Date March 5, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Non-communicating Children's Pain Checklist - Postoperative Version [ Time Frame: At Postoperative period for first 1 hour ]
The subjects will evaluate per 15 minutes for 1 hour.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
Non-communicating Children's Pain Checklist - Postoperative Version [ Time Frame: At Postoperative period every 15 minutes up to 1 hour ]
The subjects will evaluate per 15 minutes for 1 hour.
Change History Complete list of historical versions of study NCT02664857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • 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.
  • Postoperative sedation-agitation [ Time Frame: At postoperative first hour ]
    At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementations and Postoperative Pain
Official Title  ICMJE Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation
Brief Summary 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, alkaline phosphatase, terminal telopeptide C(β-CTX) 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.
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, alkaline phosphatase, terminal telopeptide C(β-CTX) 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Vitamin D
    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 Name: vitamin D supplementation
  • Drug: Placebo
    Group P will not take orally during 12 weeks. This group will only observe by researchers.
    Other Name: Observed group
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Vitamin D
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 22, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02664857
Other Study ID Numbers  ICMJE Vitamin D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ebru biricik, Cukurova University
Study Sponsor  ICMJE Cukurova University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dilek Ozcengiz, Professor Cokurova University
PRS Account Cukurova University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP