Obstructive Sleep Apnea, Tonsillitis
Conditions
Brief summary
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Detailed description
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
Interventions
DRUGHydromorphone
Patients will be randomized to one of two opioids for the treatment of post-operative pain.
DRUGFentanyl
Fentanyl
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children ages 2 to 15 years old 2. Presenting for tonsillectomy or adenotonsillectomy surgery 3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3 4. Provide Informed Consent / Assent (as appropriate)
Exclusion criteria
1. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures 2. Revision tonsillectomy or revision adenotonsillectomy surgery 3. Known pregnancy 4. Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Rescue Intravenous Opioid | up to 6 hours post surgery | Number |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Participant's Pain | Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU. | Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain |
| Evaluation of Participant's SpO2 Saturation | Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU. | SpO2 % |
| Respiratory and PONV Events in PACU | up to 6 hours following surgery | — |
| Respiratory and PONV Events at Home | up to 7 days following surgery | Survey sent to parent by email postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydromorphone Pediatric patients randomized to receive hydromorphone intravenously in the operating room. | 90 |
| Fentanyl Pediatric patients randomized to receive fentanyl intravenously in the operating room. | 90 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Investigational Pharmacy unable to provide medications in timely manner | 1 | 1 |
| Overall Study | IV inadvertently removed | 0 | 1 |
| Overall Study | Physician Decision | 2 | 3 |
Baseline characteristics
| Characteristic | Hydromorphone | Fentanyl | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 90 Participants | 90 Participants | 180 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 87 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 19 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 68 Participants | 67 Participants | 135 Participants |
| Sex: Female, Male Female | 36 Participants | 40 Participants | 76 Participants |
| Sex: Female, Male Male | 54 Participants | 50 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 15 / 90 | 12 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
Number of Patients Requiring Rescue Intravenous Opioid
Number
Time frame: up to 6 hours post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydromorphone | Number of Patients Requiring Rescue Intravenous Opioid | 48 Participants |
| Fentanyl | Number of Patients Requiring Rescue Intravenous Opioid | 66 Participants |
Secondary
Evaluation of Participant's Pain
Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone | Evaluation of Participant's Pain | 5min | 2.7 score on a scale | Standard Deviation 3.5 |
| Hydromorphone | Evaluation of Participant's Pain | 10min | 2.3 score on a scale | Standard Deviation 3.1 |
| Hydromorphone | Evaluation of Participant's Pain | 30min | 1.7 score on a scale | Standard Deviation 2.6 |
| Hydromorphone | Evaluation of Participant's Pain | 15min | 2.3 score on a scale | Standard Deviation 2.5 |
| Hydromorphone | Evaluation of Participant's Pain | 45min | 0.7 score on a scale | Standard Deviation 1.4 |
| Hydromorphone | Evaluation of Participant's Pain | 60min | 0.5 score on a scale | Standard Deviation 1.1 |
| Hydromorphone | Evaluation of Participant's Pain | 0min | 2.8 score on a scale | Standard Deviation 3.5 |
| Fentanyl | Evaluation of Participant's Pain | 60min | 2.1 score on a scale | Standard Deviation 2 |
| Fentanyl | Evaluation of Participant's Pain | 0min | 4.3 score on a scale | Standard Deviation 3.9 |
| Fentanyl | Evaluation of Participant's Pain | 5min | 3.7 score on a scale | Standard Deviation 3.9 |
| Fentanyl | Evaluation of Participant's Pain | 15min | 3.4 score on a scale | Standard Deviation 3.3 |
| Fentanyl | Evaluation of Participant's Pain | 45min | 2.4 score on a scale | Standard Deviation 2.4 |
| Fentanyl | Evaluation of Participant's Pain | 10min | 3.5 score on a scale | Standard Deviation 3.6 |
| Fentanyl | Evaluation of Participant's Pain | 30min | 2.7 score on a scale | Standard Deviation 2.9 |
Secondary
Evaluation of Participant's SpO2 Saturation
SpO2 %
Time frame: Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 10min | 97.4 percentage of SpO2 saturation | Standard Deviation 2.2 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 45min | 96.8 percentage of SpO2 saturation | Standard Deviation 2.2 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 5min | 97.3 percentage of SpO2 saturation | Standard Deviation 2.8 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 60min | 96.7 percentage of SpO2 saturation | Standard Deviation 2.3 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 30min | 96.9 percentage of SpO2 saturation | Standard Deviation 2.1 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 15min | 97.1 percentage of SpO2 saturation | Standard Deviation 2.7 |
| Hydromorphone | Evaluation of Participant's SpO2 Saturation | 0min | 96.9 percentage of SpO2 saturation | Standard Deviation 2.7 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 15min | 97.7 percentage of SpO2 saturation | Standard Deviation 2.1 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 0min | 96.6 percentage of SpO2 saturation | Standard Deviation 2.7 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 5min | 96.1 percentage of SpO2 saturation | Standard Deviation 9.6 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 10min | 97.3 percentage of SpO2 saturation | Standard Deviation 2.5 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 30min | 96.8 percentage of SpO2 saturation | Standard Deviation 9 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 45min | 97.6 percentage of SpO2 saturation | Standard Deviation 1.7 |
| Fentanyl | Evaluation of Participant's SpO2 Saturation | 60min | 97.4 percentage of SpO2 saturation | Standard Deviation 2 |
Secondary
Respiratory and PONV Events at Home
Survey sent to parent by email postoperatively
Time frame: up to 7 days following surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydromorphone | Respiratory and PONV Events at Home | Nausea since discharge | 10 Participants |
| Hydromorphone | Respiratory and PONV Events at Home | Vomiting since discharge | 7 Participants |
| Hydromorphone | Respiratory and PONV Events at Home | Problems breathing since discharge | 1 Participants |
| Hydromorphone | Respiratory and PONV Events at Home | No events | 46 Participants |
| Fentanyl | Respiratory and PONV Events at Home | No events | 35 Participants |
| Fentanyl | Respiratory and PONV Events at Home | Nausea since discharge | 13 Participants |
| Fentanyl | Respiratory and PONV Events at Home | Problems breathing since discharge | 2 Participants |
| Fentanyl | Respiratory and PONV Events at Home | Vomiting since discharge | 9 Participants |
Secondary
Respiratory and PONV Events in PACU
Time frame: up to 6 hours following surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydromorphone | Respiratory and PONV Events in PACU | Witnessed apnea in PACU | 3 Participants |
| Hydromorphone | Respiratory and PONV Events in PACU | Witnessed desaturation below 90% in PACU | 9 Participants |
| Hydromorphone | Respiratory and PONV Events in PACU | PONV in PACU | 1 Participants |
| Hydromorphone | Respiratory and PONV Events in PACU | No events | 77 Participants |
| Fentanyl | Respiratory and PONV Events in PACU | No events | 73 Participants |
| Fentanyl | Respiratory and PONV Events in PACU | Witnessed apnea in PACU | 4 Participants |
| Fentanyl | Respiratory and PONV Events in PACU | PONV in PACU | 2 Participants |
| Fentanyl | Respiratory and PONV Events in PACU | Witnessed desaturation below 90% in PACU | 11 Participants |