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A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03714919
Recruitment Status : Completed
First Posted : October 22, 2018
Results First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 22, 2018
Results First Submitted Date  ICMJE December 4, 2020
Results First Posted Date  ICMJE February 5, 2021
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE August 2, 2019
Actual Primary Completion Date November 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
Average Pain Score [ Time Frame: 1 hr post-op ]
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Pain Scores [ Time Frame: 1 hr post-op ]
Pain scores > 5 (out of 10) in the post anesthesia care unit (PACU).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • Extubation Time [ Time Frame: 1 hr post-op ]
    Amount of time in the PACU before patient is ready to be extubated.
  • Time in PACU [ Time Frame: 1-2 hr post-op ]
    Total time in PACU before patient met discharge criteria.
  • Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations [ Time Frame: 2 hours post-op ]
    Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
  • End of Surgery to Hospital Discharge [ Time Frame: 2-3 hours post-op ]
    Length of time before patient is ready to be discharged home.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Extubation Time [ Time Frame: 1 hr post-op ]
    Amount of time in the PACU before patient is ready to be extubated.
  • Time in PACU [ Time Frame: 1-2 hr post-op ]
    Total time in PACU before patient met discharge criteria.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Official Title  ICMJE A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Brief Summary This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenoid Hypertrophy
Intervention  ICMJE
  • Drug: Dextromethorphan
    Preoperative oral dextromethorphan 1 mg/kg
    Other Name: Robitussin
  • Drug: Acetaminophen
    Preoperative oral acetaminophen 15 mg/kg
    Other Name: Tylenol
  • Drug: Dexmedetomidine
    Intraoperative intravenous dexmedetomidine 0.5 μg/kg
    Other Name: Precedex
  • Drug: Ketamine
    Intraoperative intravenous ketamine 0.5 mg/kg
    Other Name: Ketalar
Study Arms  ICMJE Experimental: Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
Interventions:
  • Drug: Dextromethorphan
  • Drug: Acetaminophen
  • Drug: Dexmedetomidine
  • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 10, 2019
Actual Primary Completion Date November 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients undergoing adenoidectomy ± bilateral ear tube placement
  2. Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations

Exclusion Criteria:

  1. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
  2. A known hypersensitivity or allergy to any of the study medications;
  3. A history of chronic opioid use prior to surgery;
  4. Coexisting renal or hepatic disease;
  5. Morbid obesity (BMI% ≥ 99).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714919
Other Study ID Numbers  ICMJE IRB18-00235
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arlyne Thung, Nationwide Children's Hospital
Study Sponsor  ICMJE Arlyne Thung
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arlyne Thung, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP