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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Vitamin D Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
Group P will not take orally during 12 weeks. This group will only observe by researchers.
Other Name: Observed group
- 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.
- 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.
- Postoperative sedation-agitation [ Time Frame: At postoperative first hour ]At postoperative period, every 15 minutes up to 1 hour. Ramsey sedation scores will record.
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
|Contact: Ebru Biricik, MDfirstname.lastname@example.org|
|Contact: Nilgün Alpay, MDemail@example.com|
|Adana, Turkey, 01380|
|Contact: Ebru Biricik, MD 05052420223 firstname.lastname@example.org|
|Contact: Nilgün Alpay 05324964955 email@example.com|
|Study Chair:||Dilek Ozcengiz, Professor||Cokurova University|