Vitamin D Supplementations and Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664857
• Other study ID #: Vitamin D
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2021
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• Placebo
Group P will not take orally during 12 weeks. This group will only observe by researchers.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-communicating Children's Pain Checklist - Postoperative Version	The subjects will evaluate per 15 minutes for 1 hour.	At Postoperative period for first 1 hour
Secondary	vitamin D level	Serum vitamin D level will evaluate At first day and end of the 12 weeks.	At first day and end of the 12 weeks
Secondary	Postoperative sedation-agitation	At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.	At postoperative first hour