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

NCT03714919 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB18-00235
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoid Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Extubation Time

  1 hr post-op

• Time in PACU

  1-2 hr post-op

• Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations

  2 hours post-op

• End of Surgery to Hospital Discharge

  2-3 hours post-op

Study Arms (1)

Non-opiod pain relief

EXPERIMENTAL

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

Drug: Dextromethorphan; Drug: Acetaminophen; Drug: Dexmedetomidine; Drug: Ketamine

Interventions

Dextromethorphan DRUG

Preoperative oral dextromethorphan 1 mg/kg

Also known as: Robitussin

Non-opiod pain relief

Acetaminophen DRUG

Preoperative oral acetaminophen 15 mg/kg

Also known as: Tylenol

Non-opiod pain relief

Dexmedetomidine DRUG

Intraoperative intravenous dexmedetomidine 0.5 μg/kg

Also known as: Precedex

Non-opiod pain relief

Ketamine DRUG

Intraoperative intravenous ketamine 0.5 mg/kg

Also known as: Ketalar

Non-opiod pain relief

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arlyne Thung: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Dextromethorphan; Acetylcysteine; Acetaminophen; Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Arlyne Thung, MD
• Organization: Nationwide Children's Hospital

Arlyne.Thung@nationwidechildrens.org

614-722-4200

Study Officials

• Arlyne Thung, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 22, 2018
• Study Start: August 2, 2019
• Primary Completion: November 10, 2019
• Study Completion: November 10, 2019
• Last Updated: February 5, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)