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.

Study Overview

• Status: Completed
• Conditions: Adenoid Hypertrophy
• Intervention / Treatment: Drug: Dextromethorphan; Drug: Acetaminophen; Drug: Dexmedetomidine; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-opiod pain relief; Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.	Drug: Dextromethorphan; Preoperative oral dextromethorphan 1 mg/kg; Other Names: Robitussin; Drug: Acetaminophen; Preoperative oral acetaminophen 15 mg/kg; Other Names: Tylenol; Drug: Dexmedetomidine; Intraoperative intravenous dexmedetomidine 0.5 μg/kg; Other Names: Precedex; Drug: Ketamine; Intraoperative intravenous ketamine 0.5 mg/kg; Other Names: Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Score	Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).	1 hr post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation Time	Amount of time in the PACU before patient is ready to be extubated.	1 hr post-op
Time in PACU	Total time in PACU before patient met discharge criteria.	1-2 hr post-op
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations	Presence of sedation, nausea/vomiting, or hallucinations post-operatively.	2 hours post-op
End of Surgery to Hospital Discharge	Length of time before patient is ready to be discharged home.	2-3 hours post-op

Collaborators and Investigators

• Sponsor: Arlyne Thung
• Investigators: Principal Investigator: Arlyne Thung, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2019
• Primary Completion (Actual): November 10, 2019
• Study Completion (Actual): November 10, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Antipyretics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Respiratory System Agents; Antitussive Agents; Ketamine; Dexmedetomidine; Acetaminophen; Dextromethorphan
• Other Study ID Numbers: IRB18-00235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No