Clinical trial NCT02664857: Vitamin D Supplementations and Postoperative Pain
Official title: Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Vitamin D
Postoperative Pain
Mental Motor Retardation
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-communicating Children's Pain Checklist - Postoperative Version
timeFrame: At Postoperative period for first 1 hour
Secondary outcomes:
measure: vitamin D level
timeFrame: At first day and end of the 12 weeks
measure: Postoperative sedation-agitation
timeFrame: At postoperative first hour
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cokurova University
name: Dilek Ozcengiz, Professor
role: STUDY_CHAIR
References: