Phase 2
N=10
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Adenoid Hypertrophy
Bottom Line
View on ClinicalTrials.gov: NCT03714919 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Average Pain Score — 0 pain score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dextromethorphan (Drug); Acetaminophen (Drug); Dexmedetomidine (Drug); Ketamine (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Arlyne Thung
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Score |
— | — |
| SECONDARY Extubation Time |
23 | — |
| SECONDARY Time in PACU |
56 | — |
| SECONDARY Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations |
7; 1; 0 | — |
| SECONDARY End of Surgery to Hospital Discharge |
122 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03714919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.