A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Overview
- Phase
- Phase 2
- Intervention
- Dextromethorphan
- Conditions
- Adenoid Hypertrophy
- Sponsor
- Arlyne Thung
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Average Pain Score
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
Arlyne Thung
Attending Anesthesiologist
Nationwide Children's Hospital
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).
Arms & Interventions
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Intervention: Dextromethorphan
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Intervention: Acetaminophen
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Intervention: Dexmedetomidine
Non-opiod pain relief
Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Intervention: Ketamine
Outcomes
Primary Outcomes
Average Pain Score
Time Frame: 1 hr post-op
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Secondary Outcomes
- Time in PACU(1-2 hr post-op)
- Extubation Time(1 hr post-op)
- End of Surgery to Hospital Discharge(2-3 hours post-op)
- Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations(2 hours post-op)