search
Back to results

Vitamin D Supplementations and Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Vitamin D, Postoperative Pain, Mental Motor Retardation

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

vitamin D

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Non-communicating Children's Pain Checklist - Postoperative Version
The subjects will evaluate per 15 minutes for 1 hour.

Secondary Outcome Measures

vitamin D level
Serum vitamin D level will evaluate At first day and end of the 12 weeks.
Postoperative sedation-agitation
At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.

Full Information

First Posted
January 20, 2016
Last Updated
April 20, 2021
Sponsor
Cukurova University
search

1. Study Identification

Unique Protocol Identification Number
NCT02664857
Brief Title
Vitamin D Supplementations and Postoperative Pain
Official Title
Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Vitamin D, Postoperative Pain, Mental Motor Retardation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
vitamin D supplementation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Observed group
Intervention Description
Group P will not take orally during 12 weeks. This group will only observe by researchers.
Primary Outcome Measure Information:
Title
Non-communicating Children's Pain Checklist - Postoperative Version
Description
The subjects will evaluate per 15 minutes for 1 hour.
Time Frame
At Postoperative period for first 1 hour
Secondary Outcome Measure Information:
Title
vitamin D level
Description
Serum vitamin D level will evaluate At first day and end of the 12 weeks.
Time Frame
At first day and end of the 12 weeks
Title
Postoperative sedation-agitation
Description
At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.
Time Frame
At postoperative first hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Ozcengiz, Professor
Organizational Affiliation
Cokurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vitamin D Supplementations and Postoperative Pain

We'll reach out to this number within 24 hrs