Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Study Overview
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Brief Summary
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A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Conditions
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Obstructive Sleep Apnea, Tonsillitis

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 2 to 15 years old Presenting for tonsillectomy or adenotonsillectomy surgery American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3 Provide Informed Consent / Assent (as appropriate) Exclusion Criteria: Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures Revision tonsillectomy or revision adenotonsillectomy surgery Known pregnancy 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl<br> | Drug: Fentanyl<br>* Fentanyl<br>|
| Active Comparator: Hydromorphone<br> | Drug: Hydromorphone<br>* Patients will be randomized to one of two opioids for the treatment of post-operative pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of rescue opioid medications administered - hydromorphone group | Postoperative opioid medication expressed in morphine equivalents | up to 48 hours post surgery | 
| Amount of rescue opioid medications administered - fentanyl group | Postoperative opioid medication expressed in morphine equivalents | up to 48 hours post surgery | 
| Evaluation of participant's pain - hydromorphone group | 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 | up to 48 hours post surgery | 
| Evaluation of participant's pain - fentanyl group | 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 | up to 48 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group | Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 not at all to 5 extremely. A score of ≥11 identify anxious patients in clinical practice. | up to 12 hours prior to surgery | 
| Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group | Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure The measure of agreement with these statements should be graded on a 5-point Likert scale from 1 not at all to 5 extremely. A score of ≥11 identify anxious patients in clinical practice. | up to 12 hours prior to surgery | 
| Yale Preoperative Anxiety Scale - hydromorphone group | Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety. | up to 12 hours prior to surgery | 
| Yale Preoperative Anxiety Scale - fentanyl group | Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety. | up to 12 hours prior to surgery | 
| ASA physical status classification score from preoperative assessment - hydromorphone group | ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes | up to 12 hours prior to surgery | 
| ASA physical status classification score from preoperative assessment - fentanyl group | ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes | up to 12 hours prior to surgery | 
| Optional opioid plasma concentrations - hydromorphone group | Blood collection at three time points using mass spectroscopy (This is optional for participants) | up to 48 hours after surgery | 
| Optional opioid plasma concentrations - fentanyl group | Blood collection at three time points using mass spectroscopy (This is optional for participants) | up to 48 hours after surgery | 
| Adverse events - hydromorphone group | Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation | up to 48 hours after surgery | 
| Adverse events - fentanyl group | Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation | up to 48 hours after surgery | 
| NIH PROMIS - hydromorphone group | Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always | up to 48 hours after surgery | 
| NIH PROMIS - fentanyl group | Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always | up to 48 hours after surgery | 
| NIH PROMIS - hydromorphone group | Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always | up to 48 hours after surgery | 
| NIH PROMIS - fentanyl group | Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always | up to 48 hours after surgery | 
| Child Hospital Survey (CAHPS) - hydromorphone group | Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always | up to 48 hours after surgery | 
| Child Hospital Survey (CAHPS) - fentanyl group | Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always | up to 48 hours after surgery |