Vitamin D Supplementations and Postoperative Pain

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Vitamin D; Drug: Placebo

• Registration Number: NCT02664857
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2016-07
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin D	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Non-communicating Children's Pain Checklist - Postoperative Version	At Postoperative period for first 1 hour	The subjects will evaluate per 15 minutes for 1 hour.

Secondary Outcome Measures

Name	Time	Method
vitamin D level	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	At postoperative first hour	At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey