Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Study Details
Study Description
Brief Summary
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fentanyl
|
Drug: Fentanyl
Fentanyl
|
| Active Comparator: Hydromorphone
|
Drug: Hydromorphone
Patients will be randomized to one of two opioids for the treatment of post-operative pain.
|
Outcome Measures
Primary Outcome Measures
- Amount of rescue opioid medications administered - hydromorphone group [up to 48 hours post surgery]
Postoperative opioid medication expressed in morphine equivalents
- Amount of rescue opioid medications administered - fentanyl group [up to 48 hours post surgery]
Postoperative opioid medication expressed in morphine equivalents
- Evaluation of participant's pain - hydromorphone group [up to 48 hours post surgery]
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 pain - fentanyl group [up to 48 hours post surgery]
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
Secondary Outcome Measures
- Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group [up to 12 hours prior to surgery]
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.
- Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group [up to 12 hours prior to surgery]
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.
- Yale Preoperative Anxiety Scale - hydromorphone group [up to 12 hours prior to surgery]
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.
- Yale Preoperative Anxiety Scale - fentanyl group [up to 12 hours prior to surgery]
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.
- ASA physical status classification score from preoperative assessment - hydromorphone group [up to 12 hours prior to surgery]
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
- ASA physical status classification score from preoperative assessment - fentanyl group [up to 12 hours prior to surgery]
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
- Optional opioid plasma concentrations - hydromorphone group [up to 48 hours after surgery]
Blood collection at three time points using mass spectroscopy (This is optional for participants)
- Optional opioid plasma concentrations - fentanyl group [up to 48 hours after surgery]
Blood collection at three time points using mass spectroscopy (This is optional for participants)
- Adverse events - hydromorphone group [up to 48 hours after surgery]
Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation
- Adverse events - fentanyl group [up to 48 hours after surgery]
Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation
- NIH PROMIS - hydromorphone group [up to 48 hours after surgery]
Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
- NIH PROMIS - fentanyl group [up to 48 hours after surgery]
Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
- NIH PROMIS - hydromorphone group [up to 48 hours after surgery]
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
- NIH PROMIS - fentanyl group [up to 48 hours after surgery]
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
- Child Hospital Survey (CAHPS) - hydromorphone group [up to 48 hours after surgery]
Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always
- Child Hospital Survey (CAHPS) - fentanyl group [up to 48 hours after surgery]
Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine/Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Michael Montana, MD PhD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
- Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3. Review.
- Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.
- 201912042