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Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03783182
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Umeå University

Brief Summary:
Betamethasone is currently given routinely in conjunction with tonsillectomy surgery at the majority of Ear, Nose & Throat clinics in Sweden. The scientific evidence regarding the effects of betamethasone in adults is limited when it comes to postoperative nausea (PONV), pain and postoperative bleeding.

Condition or disease Intervention/treatment Phase
Tonsillectomy Pain PONV Bleeding Drug: Betamethason Sodium Phosphate Drug: 10% glucose solution Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, placebo controlled and randomized study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Administrator gives the study number and check the randomization list and thereafter gives the drug/placebo to a Health care personnel, who does not know if it is placebo or drug.
Primary Purpose: Treatment
Official Title: Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy - a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : June 15, 2022


Arm Intervention/treatment
Active Comparator: Betapred
16 'Betamethason Sodium Phosphate' tablets dissolved in one ml of water as part of the premedications given to the patient 30 min before the surgery
Drug: Betamethason Sodium Phosphate
Glucocorticoid
Other Name: Betapred

Placebo Comparator: Placebo
One ml of 10% glucose solution as part of the premedications given to the patient 30 min before the surgery
Drug: 10% glucose solution
Glucose solution that can be used for injection, but in this case it is used perorally (one ml)




Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 0-5 days postop ]
    Nausea/Vomiting postoperatively, numeric Visual Analogue Scale graded from 0 to 10, where 10 is the worst grade of nausea


Secondary Outcome Measures :
  1. Pain [ Time Frame: 0-5 days postop ]
    Postoperative pain, numeric Visual Analogue Scale, graded from 0 to 10, where grade 10 is the worse pain


Other Outcome Measures:
  1. Bleeding [ Time Frame: 0-30 days postop ]
    Postoperative bleeding, visits to Health care. Medical records of the patients are used retrospectively in order to detect any postoperative bleeding that has caused a Contact with the Health care. Such events are divided in a) no of events not demanding new surgery and b) no of events demanding hemostasis by new surgery.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Signed informed consent Age over 12 years Planned for elective bilateral tonsillectomy

Exclusion Criteria:

  • • Insulin dependent diabetes mellitus

    • NSAID or corticosteroid intolerance
    • Pregnancy
    • Gastric ulcer
    • Immunodeficiency
    • Treatment for chronic pain
    • Psychiatric disorders

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): NCT03783182


Contacts
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Contact: Krister Tano, MD, PhD 0046705569043 krister.tano@umu.se
Contact: My Rosén, MD 0046920283156 my.rosen@norrbotten.se

Locations
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Sweden
Sunderby sjukhus Recruiting
Luleå, Sweden, 971 80
Contact: Krister Tano, PhD, MD    0046705569043    krister.tano@umu.se   
Contact: My Rosen, MD       my.rosen@norrbotten.se   
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Krister Tano, MD, PhD Umeå University

Publications:
Johansson U, Sundgren C, Tano K, van den Berg J. The effect of Perioperative Bethamethasone on Post-operative Nausea, Vomiting and Pain in Children undergoing Tonsillar Surgery. British Journal of Anaesthetic&Recovery Nursing. 2011;11:24-29.

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03783182     History of Changes
Other Study ID Numbers: Eudract: 2018-001261-16
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone sodium phosphate
Vomiting
Postoperative Nausea and Vomiting
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Nausea
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents