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Dexamethasone and Post-tonsillectomy Pain in Children

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ClinicalTrials.gov Identifier: NCT02793011
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Olubukola Nafiu, University of Michigan

Brief Summary:

The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:

  • Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
  • Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
  • Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.

Condition or disease Intervention/treatment Phase
Pediatric Post-tonsillectomy Pain Drug: Dexamethasone Drug: Placebo Phase 4

Detailed Description:

(See brief summary as well)

The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
Study Start Date : June 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Dexamethasone
Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Drug: Dexamethasone
Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate
Other Name: corticosteroid

Placebo Comparator: Placebo
Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
Drug: Placebo
Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule




Primary Outcome Measures :
  1. Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay [ Time Frame: 0-8 hours postoperatively ]
    Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.


Secondary Outcome Measures :
  1. Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese). [ Time Frame: 0-8 hours postoperatively ]
    Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.

  2. Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed. [ Time Frame: 0-8 hours postoperatively ]
    Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital

Exclusion Criteria:

  • Known hypersensitivity to dexamethasone
  • Developmental delay
  • Taking chronic analgesics
  • Taking chronic systemic steroids
  • Treatment with steroids in last 30 days
  • Cushings or Prader-Willi or Nephrotic Syndromes
  • Diabetes Mellitus

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): NCT02793011


Contacts
Contact: Olubukola Nafiu, MD 734 936 4280 onafiu@med.umich.edu
Contact: Monica Weber, RN BSN CCRP 734 936 0734 monij@med.umich.edu

Locations
United States, Michigan
University of Michigan C.S. Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Olubukola Nafiu, MD University of Michigan, CS Mott Children's Hospital, Dept of Otolaryngology

Responsible Party: Olubukola Nafiu, Assistant Professor of Anesthesiology, University of Michigan Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT02793011     History of Changes
Other Study ID Numbers: HUM00084860
5K23GM104354 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action