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

Study Overview
=================
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.

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

Conditions
-----------------
Adenoid Hypertrophy

Intervention / Treatment
-----------------
* Drug: Dextromethorphan
* Drug: Acetaminophen
* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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