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Completed

NCT Number: NCT03714919

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

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.

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Key information

Conditions

Adenoid Hypertrophy

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing adenoidectomy ± bilateral ear tube placement
  • 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

  • An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
  • A known hypersensitivity or allergy to any of the study medications;
  • A history of chronic opioid use prior to surgery;
  • Coexisting renal or hepatic disease;
  • Morbid obesity (BMI% ≥ 99).

Treatment and study plan

dextromethorphan

Drug

Preoperative oral dextromethorphan 1 mg/kg

Other names: Robitussin

Acetaminophen

Drug

Preoperative oral acetaminophen 15 mg/kg

Other names: Tylenol

Dexmedetomidine

Drug

Intraoperative intravenous dexmedetomidine 0.5 μg/kg

Other names: Precedex

ketamine

Drug

Intraoperative intravenous ketamine 0.5 mg/kg

Other names: Ketalar

Primary outcomes

  1. 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).

Secondary outcomes

  1. Extubation Time

    Time frame: 1 hr post-op

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

  2. Time in PACU

    Time frame: 1-2 hr post-op

    Total time in PACU before patient met discharge criteria.

  3. Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations

    Time frame: 2 hours post-op

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

  4. End of Surgery to Hospital Discharge

    Time frame: 2-3 hours post-op

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

Sponsors and collaborators

Lead sponsor

Arlyne Thung

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2018
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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