NCT03618823

Non-opioids for Analgesia After Adenotonsillectomy in Children

Terminated Phase 1, PHASE2 Results posted Last updated 10 November 2021

What this trial tests

Phase 1, PHASE2 trial testing Oxycodone in Adenotonsillectomy in 268 participants. Terminated before completion.

Timeline

25 October 2018

Primary endpoint
18 May 2020

18 May 2020

Quick facts

Lead sponsor	David Chi, MD
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	268
Start date	25 October 2018
Primary completion	18 May 2020
Estimated completion	18 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Oxycodone (oxycodone) — full drug profile →
• Ibuprofen (ibuprofen) — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →

Conditions studied

• Adenotonsillectomy — all drugs for Adenotonsillectomy →
• Post-operative Analgesia — all drugs for Post-operative Analgesia →
• Opioid Use — all drugs for Opioid Use →

Sponsor

David Chi, MD

Who can join

Adults 3 to 17, any sex, with Adenotonsillectomy or Post-operative Analgesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Pain Burden Primary · 14 days post-operatively

Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain.

Before

Group	Value	95% CI
Opioid Pain Control Group	5.78	± 0.25
Non-opioid Pain Control Group	5.66	± 0.23

After

Group	Value	95% CI
Opioid Pain Control Group	2.33	± 0.22
Non-opioid Pain Control Group	2.24	± 0.21

Number of Participants With ED (Emergency Department) or Urgent Care Visits Secondary · 14 days post-operatively

Number of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary.

Group	Value	95% CI
Opioid Pain Control	8
Non-opioid Pain Control	11

Number of Side Effects of Medications Secondary · 14 days post-operatively

Number of any of the following side effects experienced: Nausea, vomiting, constipation, stomach ache, difficulty breathing. Assessed at follow-up and take-home pain diary.

Group	Value	95% CI
Opioid Pain Control	38
Non-opioid Pain Control	35
Opioid Pain Control	10
Non-opioid Pain Control	22
Opioid Pain Control	7
Non-opioid Pain Control	7
Opioid Pain Control	9
Non-opioid Pain Control	2

Number of Participants With Readmissions Secondary · 14 days post-operatively

Number of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary.

Group	Value	95% CI
Opioid Pain Control	3
Non-opioid Pain Control	8

Average Dose of Each Analgesic Used Secondary · 14 days post-operatively

In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used.

Acetaminophen

Group	Value	95% CI
Opioid Pain Control	6.54	± 2.87
Non-opioid Pain Control	7.52	± 6.47

Ibuprofen

Group	Value	95% CI
Opioid Pain Control	7.53	± 4.08
Non-opioid Pain Control	7.53	± 4.74

Oxycodone

Group	Value	95% CI
Opioid Pain Control	0.13	± 0.19
Non-opioid Pain Control	0.04	± 0.24

Duration of Each Analgesic Used Secondary · 14 days post-operatively

Using the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use.

Acetaminophen

Group	Value	95% CI
Opioid Pain Control	8.61	± 2.97
Non-opioid Pain Control	8.64	± 3.40

Ibuprofen

Group	Value	95% CI
Opioid Pain Control	8.49	± 3.42
Non-opioid Pain Control	8.75	± 3.46

Oxycodone

Group	Value	95% CI
Opioid Pain Control	2.62	± 2.90
Non-opioid Pain Control	0.45	± 1.66

Mean of Total Quantity of Pain Medications Taken Secondary · 14 days post-operatively

Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported.

Acetaminophen

Group	Value	95% CI
Opioid Pain Control	292.48	± 178.73
Non-opioid Pain Control	326.98	± 269.66

Ibuprofen

Group	Value	95% CI
Opioid Pain Control	324.14	± 225.70
Non-opioid Pain Control	334.65	± 234.18

Oxycodone

Group	Value	95% CI
Opioid Pain Control	6.47	± 9.89
Non-opioid Pain Control	2.96	± 14.84

Overall Pain Relief Satisfaction Secondary · 14 days post-operatively

Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement "I am happy with the pain relief I received in the last 14 days" with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome.

Group	Value	95% CI
Opioid Pain Control	3.35	± 0.79
Non-opioid Pain Control	3.09	± 0.96

Post-operative Nursing Phone Calls Secondary · 14 days post-operatively

Number of post-operative phone calls to nursing staff, obtained using the electronic medical record.

Group	Value	95% CI
Opioid Pain Control	0.35	± 0.66
Non-opioid Pain Control	0.47	± 0.79

Number of Night-time Awakenings Secondary · 14 days post-operatively

Number of night-time awakenings reported in 14 days - assessed via the take-home pain diary.

Group	Value	95% CI
Opioid Pain Control	10
Non-opioid Pain Control	13
Opioid Pain Control	33
Non-opioid Pain Control	28
Opioid Pain Control	19
Non-opioid Pain Control	18
Opioid Pain Control	3
Non-opioid Pain Control	7

Non-opioid Group Switching to Opioid Group Secondary · 14 days post-operatively

Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary.

Group	Value	95% CI
Non-opioid Pain Control	7

Need for Follow-up Appointment Secondary · two months post-operatively

Does the parent/guardian believe his/her child would require a follow-up appointment - assessed using the individual pain diary.

Group	Value	95% CI
Opioid Pain Control	7
Non-opioid Pain Control	11
Opioid Pain Control	54
Non-opioid Pain Control	49
Opioid Pain Control	8
Non-opioid Pain Control	15

Adverse events — posted to ClinicalTrials.gov

Time frame: 5-9 weeks depending on the date of the follow-up appointment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Opioid Pain Control

Serious: 9/149 (6%)

Deaths: 0/149

Non-opioid Pain Control

Serious: 4/119 (3%)

Deaths: 0/119

Serious adverse events (3 terms)

Reaction	System	Opioid Pain Control	Non-opioid Pain Control
Post-Tonsillectomy Hemorrhage Requiring Operative Intervention	Surgical and medical procedures	—	—
Dehydration Requiring Inpatient Admission	General disorders	—	—
Oxygen Desaturation	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Opioid Pain Control	Non-opioid Pain Control
Nursing Phone Call for Pain	General disorders	—	—
Post-Tonsillectomy Hemorrhage Not Requiring Operative Intervention	Vascular disorders	—	—
Nausea or Vomiting	General disorders	—	—
Emergency Department Visit for Pain	General disorders	—	—

Most-reported serious reactions: Post-Tonsillectomy Hemorrhage Requiring Operative Intervention, Dehydration Requiring Inpatient Admission, Oxygen Desaturation.

Data from ClinicalTrials.gov NCT03618823 adverse events section.

Sponsor's own description

The goal of this study is to determine if non-opioid pain control is a safe way to manage pain after adenotonsillectomy surgery in children. The investigators will be randomly assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain medication only, and the other group will receive opioid and non-opioid medications for pain control. The investigators will analyze the data and determine if there is a difference in pain control between the two drug regimens, and if there are any other associated complications between the two groups.

This study is important because if we can demonstrate that there is little difference in outcomes and pain control between the two groups, a strong argument can be made for reducing or eliminating opioid prescription after adenotonsillectomy. This may protect future children from the risks of taking opioid medications and help to reduce the scope of the opioid epidemic.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Opioid Analgesia Following Pediatric Adenotonsillectomy: A Randomized Clinical Trial.
   Whelan RL, McCoy JL, Mirson L, Maguire RC, et al · · 2025 · cited 1× · PMID 40396501 · DOI 10.1002/ohn.1280