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Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery

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ClinicalTrials.gov Identifier: NCT04042948
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
This study evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Lumbar Disc Herniation Lumbar Radiculopathy Drug: Tylenol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Randomized control parallel
Primary Purpose: Prevention
Official Title: Randomized Controlled Study of Fever Probability, Risk Factors and Preventive Use of Non-steroidal Anti-inflammatory Drugs on Fever After Removal of Drainage Tube After Lumbar Fusion
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Experimental Group
preventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube
Drug: Tylenol
when we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later

No Intervention: Control Group
without any intervention when remove the drainage tube



Primary Outcome Measures :
  1. the rate of fever after the removal of drainage tube [ Time Frame: 24 hours ]
    we test the temperature of the patient in 24h after the removal of tube, we define fever if the temperature is higher than 37.8 degree


Secondary Outcome Measures :
  1. the level of WBC [ Time Frame: 24 hours ]
    we compare the change of the level of WBC of two groups in 24h after the removal of the drainage tube

  2. the level of CRP [ Time Frame: 24 hours ]
    we compare the change of the level of CRP of two groups in 24h after the removal of the drainage tube

  3. the level of ESR [ Time Frame: 24 hours ]
    we compare the change of the level of ESR of two groups in 24h after the removal of the drainage tube

  4. the temperature [ Time Frame: 24 hours ]
    we compare the change of the level of temperature of two groups in 24h after the removal of the drainage tube



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patient
  • diagnosis of lumbar spinal stenosis
  • perform decompression and fusion surgery and lay a drainage tube
  • understand the test and could sign the name

Exclusion Criteria:

  • beside the inclusion criteria

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): NCT04042948


Contacts
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Contact: Yun Tian, M.D +86 13701053505 tiany@bjmu.edu.cn

Locations
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China, Haidian
Peking University Third Hospital Recruiting
Beijing, Haidian, China, 110191
Contact: Kaifeng Ye, B.S    +86 17610768979    kaifengye@bjmu.edu.cn   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Yun Tian, M.D Peking University Third Hospital, Beijing, China

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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04042948    
Other Study ID Numbers: IRB00006761-M2019299
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
lumbar spinal stenosis
lumbar fusion surgery
drainage tube
removal of drainage tube
fever
prevention of fever
preventive use of non-steroidal inflammatory drug
Additional relevant MeSH terms:
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Spinal Stenosis
Radiculopathy
Fever
Body Temperature Changes
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antirheumatic Agents