Back to resultsA Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Primary Purpose
Adenoid Hypertrophy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Acetaminophen
Dexmedetomidine
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Adenoid Hypertrophy
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing adenoidectomy ยฑ 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 โฅ 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% โฅ 99).
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-opiod pain relief
Arm Description
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
Outcomes
Primary Outcome Measures
Average Pain Score
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Secondary Outcome Measures
Extubation Time
Amount of time in the PACU before patient is ready to be extubated.
Time in PACU
Total time in PACU before patient met discharge criteria.
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
End of Surgery to Hospital Discharge
Length of time before patient is ready to be discharged home.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03714919
Brief Title
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Official Title
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
November 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arlyne Thung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-opiod pain relief
Arm Type
Experimental
Arm Description
Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine.
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Other Intervention Name(s)
Robitussin
Intervention Description
Preoperative oral dextromethorphan 1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Preoperative oral acetaminophen 15 mg/kg
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Intraoperative intravenous dexmedetomidine 0.5 ฮผg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Intraoperative intravenous ketamine 0.5 mg/kg
Primary Outcome Measure Information:
Title
Average Pain Score
Description
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Time Frame
1 hr post-op
Secondary Outcome Measure Information:
Title
Extubation Time
Description
Amount of time in the PACU before patient is ready to be extubated.
Time Frame
1 hr post-op
Title
Time in PACU
Description
Total time in PACU before patient met discharge criteria.
Time Frame
1-2 hr post-op
Title
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Description
Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
Time Frame
2 hours post-op
Title
End of Surgery to Hospital Discharge
Description
Length of time before patient is ready to be discharged home.
Time Frame
2-3 hours post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing adenoidectomy ยฑ 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 โฅ 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% โฅ 99).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlyne Thung, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
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