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

Ketamine

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.

Intervention / Treatment

  • Dextromethorphan (DRUG)
    Preoperative oral dextromethorphan 1 mg/kg
  • Acetaminophen (DRUG)
    Preoperative oral acetaminophen 15 mg/kg
  • Dexmedetomidine (DRUG)
    Intraoperative intravenous dexmedetomidine 0.5 μg/kg
  • Ketamine (DRUG)
    Intraoperative intravenous ketamine 0.5 mg/kg

Condition or Disease

  • Adenoid Hypertrophy

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 4 Years to 8 Years
    Enrollment: 10 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

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    Clinical Trial Dates

    Start date: Aug 02, 2019 ACTUAL
    Primary Completion: Nov 10, 2019 ACTUAL
    Completion Date: Nov 10, 2019 ACTUAL
    Study First Posted: Oct 22, 2018 ACTUAL
    Results First Posted: Feb 05, 2021 ACTUAL
    Last Updated: Jan 19, 2021

    Sponsors / Collaborators

    Lead Sponsor: Arlyne Thung
    Responsible Party: Arlyne Thung

    Location

    Columbus, Ohio, USA

    Participant Groups

    • Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.

    Eligibility Criteria

    Sex: All
    Minimum Age: 4
    Maximum Age: 8
    Age Groups: Child
    Healthy Volunteers: Yes

    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).

    Primary Outcomes

    • Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).

    Secondary Outcomes

    • Amount of time in the PACU before patient is ready to be extubated.

    • Total time in PACU before patient met discharge criteria.

    • Presence of sedation, nausea/vomiting, or hallucinations post-operatively.

    • Length of time before patient is ready to be discharged home.

    More Details

    NCT Number: NCT03714919
    Other IDs: IRB18-00235
    Study URL: https://clinicaltrials.gov/study/NCT03714919
    Last updated: Sep 29, 2023