Vitamin D Supplementations and Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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
      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 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.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; Group P will not take orally during 12 weeks. This group will only observe by researchers.
Other intervention name(s): vitamin D supplementation; Observed group
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vitamin D; Postoperative Pain; Mental Motor Retardation