Adenoid Hypertrophy
Conditions
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.
Interventions
DRUGDextromethorphan
Preoperative oral dextromethorphan 1 mg/kg
DRUGAcetaminophen
Preoperative oral acetaminophen 15 mg/kg
DRUGDexmedetomidine
Intraoperative intravenous dexmedetomidine 0.5 μg/kg
DRUGKetamine
Intraoperative intravenous ketamine 0.5 mg/kg
Sponsors
Arlyne Thung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | 2 hours post-op | Presence of sedation, nausea/vomiting, or hallucinations post-operatively. |
| End of Surgery to Hospital Discharge | 2-3 hours post-op | Length of time before patient is ready to be discharged home. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-opiod Pain Relief 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Non-opiod Pain Relief | — |
|---|---|---|
| Age, Categorical <=18 years | 10 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 5 years | — |
| ASA 1 | 6 participants | — |
| ASA 2 | 4 participants | — |
| Height | 110 centimeters | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
| Weight | 20.5 kilograms | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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).
Time frame: 1 hr post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-opiod Pain Relief | Average Pain Score | 0 pain score | Standard Deviation 0 |
Secondary
End of Surgery to Hospital Discharge
Length of time before patient is ready to be discharged home.
Time frame: 2-3 hours post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-opiod Pain Relief | End of Surgery to Hospital Discharge | 122 minutes |
Secondary
Extubation Time
Amount of time in the PACU before patient is ready to be extubated.
Time frame: 1 hr post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-opiod Pain Relief | Extubation Time | 23 minutes |
Secondary
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
Presence of sedation, nausea/vomiting, or hallucinations post-operatively.
Time frame: 2 hours post-op
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-opiod Pain Relief | Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | Sedation | 7 participants |
| Non-opiod Pain Relief | Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | Nausea/Vomiting | 1 participants |
| Non-opiod Pain Relief | Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations | Hallucinations | 0 participants |
Secondary
Time in PACU
Total time in PACU before patient met discharge criteria.
Time frame: 1-2 hr post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-opiod Pain Relief | Time in PACU | 56 minutes |