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

Phase 2

Completed

• Conditions: Adenoid Hypertrophy
• Interventions: Drug: Dextromethorphan; Drug: Acetaminophen; Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT03714919
• Lead Sponsor: Arlyne Thung

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-22
• Study Start: 2019-08-02
• Primary Completion: 2019-11-10
• Study Completion: 2019-11-10
• Results First Submitted: 2020-12-04
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Results First Posted: 2021-02-05
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-opiod pain relief	Acetaminophen	Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Non-opiod pain relief	Dextromethorphan	Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Non-opiod pain relief	Dexmedetomidine	Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.
Non-opiod pain relief	Ketamine	Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.

Primary Outcome Measures

Name	Time	Method
Average Pain Score	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 Outcome Measures

Name	Time	Method
Extubation Time	1 hr post-op	Amount of time in the PACU before patient is ready to be extubated.
Time in PACU	1-2 hr post-op	Total time in PACU before patient met discharge criteria.
End of Surgery to Hospital Discharge	2-3 hours post-op	Length of time before patient is ready to be discharged home.
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations	2 hours post-op	Presence of sedation, nausea/vomiting, or hallucinations post-operatively.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States