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

• Sponsor: Arlyne Thung (Other)
• Overall Status: Completed
• CT.gov ID: NCT03714919
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenoid Hypertrophy	Drug: Dextromethorphan; Drug: Acetaminophen; Drug: Dexmedetomidine; Drug: Ketamine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
• Actual Study Start Date: Aug 2, 2019
• Actual Primary Completion Date: Nov 10, 2019
• Actual Study Completion Date: Nov 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Extubation Time [1 hr post-op]

   Amount of time in the PACU before patient is ready to be extubated.

2. Time in PACU [1-2 hr post-op]

   Total time in PACU before patient met discharge criteria.

3. Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations [2 hours post-op]

   Presence of sedation, nausea/vomiting, or hallucinations post-operatively.

4. End of Surgery to Hospital Discharge [2-3 hours post-op]

   Length of time before patient is ready to be discharged home.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Arlyne Thung

Investigators

• Principal Investigator: Arlyne Thung, MD, Nationwide Children's Hospital

Study Documents (Full-Text)

• Study Protocol - Apr 8, 2019

More Information

Publications

None provided.

• Responsible Party: Arlyne Thung, Attending Anesthesiologist, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT03714919
• Other Study ID Numbers: IRB18-00235
• First Posted: Oct 22, 2018
• Last Update Posted: Feb 5, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertrophy; Acetaminophen; Dexmedetomidine; Ketamine; Dextromethorphan

Study Results

Participant Flow

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Overall Participants	10
Age (Count of Participants)
<=18 years	10 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	5
Sex: Female, Male (Count of Participants)
Female	5 50%
Male	5 50%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	10 100%
Weight (kilograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kilograms]	20.5
Height (centimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [centimeters]	110
ASA 1 (participants) [Number]
Number [participants]	6 60%
ASA 2 (participants) [Number]
Number [participants]	4 40%

Outcome Measures

1. Primary Outcome

Title	Average Pain Score
Description	Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).
Time Frame	1 hr post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Measure Participants	10
Mean (Standard Deviation) [pain score]	0 (0)

2. Secondary Outcome

Title	Extubation Time
Description	Amount of time in the PACU before patient is ready to be extubated.
Time Frame	1 hr post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Measure Participants	10
Median (Inter-Quartile Range) [minutes]	23

3. Secondary Outcome

Title	Time in PACU
Description	Total time in PACU before patient met discharge criteria.
Time Frame	1-2 hr post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Measure Participants	10
Median (Inter-Quartile Range) [minutes]	56

4. Secondary Outcome

Title	Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Description	Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
Time Frame	2 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Measure Participants	10
Sedation	7 70%
Nausea/Vomiting	1 10%
Hallucinations	0 0%

5. Secondary Outcome

Title	End of Surgery to Hospital Discharge
Description	Length of time before patient is ready to be discharged home.
Time Frame	2-3 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
Measure Participants	10
Median (Inter-Quartile Range) [minutes]	122

Adverse Events

Time Frame	72 hours post-op
Arm/Group Title	Non-opiod Pain Relief
Arm/Group Description	Subjects will receive preoperative oral dextromethorphan & acetaminophen and intraoperative intravenous dexmedetomidine & ketamine. 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
All Cause Mortality
	Non-opiod Pain Relief
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Non-opiod Pain Relief
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Non-opiod Pain Relief
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.