The Effect of Vitamin D3 on Postoperative Pain in Patients Undergoing Craniotomy

Study Overview
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Brief Summary
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Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have shown vitamin D has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be effective on reduce pain by such mechanisms. In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to the control group.

Detailed Description
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A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU) and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be carefully checked for inclusion and exclusion criteria. Then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.These patients will be divided into two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin D (300000 IU),while another group will not receive. Pain in patients will be checked daily by up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.

Official Title
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The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection

Conditions
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Brain Neoplasms

Intervention / Treatment
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* Drug: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent of patient or legal representative 25(OH)D level below 20ng/dL Exclusion Criteria: Other trial participation, including previous participation in the pilot trial Pregnant or lactating women Hypercalcemia Hyperphosphatemia Tuberculosis Sarcoidosis History of nephrolithiasis History of hyperparathyroidism Medications that interfere with vitamin D metabolism Renal Insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection | Drug: vitamin D<br>* Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection<br>* Other names: Cholecalciferol;|
| No Intervention: control<br>Control patients will not be received any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale | By questioning from patients for daily pain intensity based on the VAS scale in which pain intensity score by 0 to 10. The 0 and 10 score indicates no pain and worst pain,respectively. also 1-3 , 4-6 and 7-9 score indicates mild, mild to moderate and severe pain, respectively. | Up to three days after surgery |