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

June 17, 2021 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Haidian
      • Beijing, Haidian, China, 110191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
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
24 hours
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
24 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yun Tian, M.D, Peking University Third Hospital, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006761-M2019299

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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