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

Adenoid Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714919
• Other study ID #: IRB18-00235
• Status: Completed
• Phase: Phase 2
• Start date: August 2, 2019
• Est. completion date: November 10, 2019

Study information

• Verified date: January 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 10, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

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).

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy

Intervention

Drug:
• Dextromethorphan
Preoperative oral dextromethorphan 1 mg/kg
• Acetaminophen
Preoperative oral acetaminophen 15 mg/kg
• Dexmedetomidine
Intraoperative intravenous dexmedetomidine 0.5 µg/kg
• Ketamine
Intraoperative intravenous ketamine 0.5 mg/kg

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arlyne Thung

Country where clinical trial is conducted

United States, 

Outcome

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