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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2019-11-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Adenoid Hypertrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-opiod pain relief

Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine.

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Preoperative oral dextromethorphan 1 mg/kg

Acetaminophen

Intervention Type DRUG

Preoperative oral acetaminophen 15 mg/kg

Dexmedetomidine

Intervention Type DRUG

Intraoperative intravenous dexmedetomidine 0.5 μg/kg

Ketamine

Intervention Type DRUG

Intraoperative intravenous ketamine 0.5 mg/kg

Interventions

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Dextromethorphan

Preoperative oral dextromethorphan 1 mg/kg

Intervention Type DRUG

Acetaminophen

Preoperative oral acetaminophen 15 mg/kg

Intervention Type DRUG

Dexmedetomidine

Intraoperative intravenous dexmedetomidine 0.5 μg/kg

Intervention Type DRUG

Ketamine

Intraoperative intravenous ketamine 0.5 mg/kg

Intervention Type DRUG

Other Intervention Names

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Robitussin Tylenol Precedex Ketalar

Eligibility Criteria

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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).

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No