Skip to main content
OpenTrials
Completed

NCT Number: NCT02664857

Vitamin D Supplementations and Postoperative Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University

Adana, 01380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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 names: vitamin D supplementation

Placebo

Drug

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

Other names: Observed group

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Postoperative sedation-agitation

    Time frame: At postoperative first hour

    At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.