Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Supplementations and Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02664857
Recruitment Status : Unknown
Verified March 2017 by ebru biricik, Cukurova University.
Recruitment status was:  Recruiting
First Posted : January 27, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
ebru biricik, 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, alkaline phosphatase, terminal telopeptide C(β-CTX) 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Vitamin D Drug: Placebo Phase 4

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, alkaline phosphatase, terminal telopeptide C(β-CTX) 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation
Study Start Date : July 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 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.
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
Other Name: vitamin D supplementation

Sham Comparator: 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.
Drug: Placebo
Group P will not take orally during 12 weeks. This group will only observe by researchers.
Other Name: Observed group




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664857


Contacts
Layout table for location contacts
Contact: Ebru Biricik, MD +905052420223 ebrubiricik@mynet.com
Contact: Nilgün Alpay, MD +905324964955 nilgunalpay@yahoo.com

Locations
Layout table for location information
Turkey
Cukurova University Recruiting
Adana, Turkey, 01380
Contact: Ebru Biricik, MD    05052420223    ebrubiricik@mynet.com   
Contact: Nilgün Alpay    05324964955    nilgunalpay@yahoo.com   
Sponsors and Collaborators
Cukurova University
Investigators
Layout table for investigator information
Study Chair: Dilek Ozcengiz, Professor Cokurova University

Layout table for additonal information
Responsible Party: ebru biricik, Medical Doctor, Cukurova University
ClinicalTrials.gov Identifier: NCT02664857     History of Changes
Other Study ID Numbers: Vitamin D
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ebru biricik, Cukurova University:
Vitamin D
Postoperative Pain
Mental Motor Retardation

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents