Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714919
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Adenoid Hypertrophy Drug: Dextromethorphan Drug: Acetaminophen Drug: Dexmedetomidine Drug: Ketamine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

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 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




Primary Outcome Measures :
  1. Pain scores [ Time Frame: 1 hr post-op ]
    Pain scores > 5 (out of 10) in the post anesthesia care unit (PACU).


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714919


Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Arlyne Thung
Investigators
Layout table for investigator information
Principal Investigator: Arlyne Thung, MD Nationwide Children's Hospital

Layout table for additonal information
Responsible Party: Arlyne Thung, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03714919    
Other Study ID Numbers: IRB18-00235
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertrophy
Pathological Conditions, Anatomical
Acetaminophen
Dexmedetomidine
Analgesics, Non-Narcotic
Ketamine
Dextromethorphan
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antipyretics
Antitussive Agents
Respiratory System Agents