Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230681
• Other study ID #: 201912042
• Status: Completed
• Phase: Early Phase 1
• Start date: February 26, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Drug:
• Hydromorphone
Patients will be randomized to one of two opioids for the treatment of post-operative pain.
• Fentanyl
Fentanyl

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of rescue opioid medications administered - hydromorphone group	Postoperative opioid medication expressed in morphine equivalents	up to 48 hours post surgery
Primary	Amount of rescue opioid medications administered - fentanyl group	Postoperative opioid medication expressed in morphine equivalents	up to 48 hours post surgery
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events - hydromorphone group	Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation	up to 48 hours after surgery
Secondary	Adverse events - fentanyl group	Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation	up to 48 hours after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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