NCT02358850

Brief Summary

This is a randomized prospective study to determine the optimal postoperative pain medication regimen for adults (18 years old and older) undergoing tonsillectomy with or without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All participants will undergo the same tonsillectomy surgical technique (with or without adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain control regimens (all of which are commonly used pain medications for post-tonsillectomy pain):

  1. 1.Norco (Hydrocodone and Acetaminophen)
  2. 2.Percocet (Oxycodone and Acetaminophen)
  3. 3.Dilaudid and Tylenol (Acetaminophen)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

January 14, 2015

Last Update Submit

July 11, 2023

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative HemorrhageBody Weight Changes

Keywords

TonsillectomyAdenoidectomy

Outcome Measures

Primary Outcomes (14)

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 1

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 2

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 3

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 4

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 5

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 6

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 7

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 8

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 9

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 10

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 11

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 12

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 13

  • Daily pain level

    Daily pain level on scale from 0-10

    Postoperative day 14

Secondary Outcomes (31)

  • Daily oral liquid intake

    Postoperative day 1

  • Daily oral liquid intake

    Postoperative day 2

  • Daily oral liquid intake

    Postoperative day 3

  • Daily oral liquid intake

    Postoperative day 4

  • Daily oral liquid intake

    Postoperative day 5

  • +26 more secondary outcomes

Study Arms (3)

Tonsillectomy and Norco

ACTIVE COMPARATOR

This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen)

Drug: Norco (Hydrocodone and Acetaminophen)

Tonsillectomy and Percocet

ACTIVE COMPARATOR

This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen)

Drug: Percocet (Oxycodone and Acetaminophen)

Tonsillectomy and Dilaudid + Tylenol

ACTIVE COMPARATOR

This represents patients who will be randomized (1:3 chance) to postoperative pain control with Dilaudid (hydromorphone) and Tylenol (Acetaminophen)

Drug: Dilaudid (hydromorphone)Drug: Tylenol (Acetaminophen)

Interventions

Norco (Hydrocodone and Acetaminophen)DRUG

Norco (Hydrocodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN (as needed) pain following Tonsillectomy for 14 days

Also known as: Norco
Tonsillectomy and Norco
Percocet (Oxycodone and Acetaminophen)DRUG

Percocet (Oxycodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

Also known as: Percocet
Tonsillectomy and Percocet
Dilaudid (hydromorphone)DRUG

Dilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

Also known as: Dilaudid
Tonsillectomy and Dilaudid + Tylenol
Tylenol (Acetaminophen)DRUG

Tylenol (Acetaminophen) 325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

Also known as: Tylenol
Tonsillectomy and Dilaudid + Tylenol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea
  • Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also include Adenoidectomy with suction cautery

You may not qualify if:

  • Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery
  • Pregnant females
  • Indications: Suspected malignancy
  • History of chronic pain or daily pain medication used for another medical problem
  • History of liver disease
  • Contraindications to preoperative Decadron
  • Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (9)

  • Lee SW, Jeon SS, Lee JD, Lee JY, Kim SC, Koh YW. A comparison of postoperative pain and complications in tonsillectomy using BiClamp forceps and electrocautery tonsillectomy. Otolaryngol Head Neck Surg. 2008 Aug;139(2):228-34. doi: 10.1016/j.otohns.2008.04.004.

    PMID: 18656720BACKGROUND

  • Parsons SP, Cordes SR, Comer B. Comparison of posttonsillectomy pain using the ultrasonic scalpel, coblator, and electrocautery. Otolaryngol Head Neck Surg. 2006 Jan;134(1):106-13. doi: 10.1016/j.otohns.2005.09.027.

    PMID: 16399189BACKGROUND

  • Noordzij JP, Affleck BD. Coblation versus unipolar electrocautery tonsillectomy: a prospective, randomized, single-blind study in adult patients. Laryngoscope. 2006 Aug;116(8):1303-9. doi: 10.1097/01.mlg.0000225944.00189.e9.

    PMID: 16885729BACKGROUND

  • Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.

    PMID: 21812940BACKGROUND

  • Thorneman G, Akervall J. Pain treatment after tonsillectomy: advantages of analgesics regularly given compared with analgesics on demand. Acta Otolaryngol. 2000 Oct;120(8):986-9. doi: 10.1080/00016480050218744.

    PMID: 11200596BACKGROUND

  • Naesh O, Niles LA, Gilbert JG, Ammar MM, Phibbs PW, Phillips AM, Khrapov AV, Robert AJ, McClintock A. A randomized, placebo-controlled study of rofecoxib with paracetamol in early post-tonsillectomy pain in adults. Eur J Anaesthesiol. 2005 Oct;22(10):768-73. doi: 10.1017/s0265021505001274.

    PMID: 16211736BACKGROUND

  • Hiller A, Silvanto M, Savolainen S, Tarkkila P. Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy. Acta Anaesthesiol Scand. 2004 Oct;48(9):1185-9. doi: 10.1111/j.1399-6576.2004.00473.x.

    PMID: 15352967BACKGROUND

  • Salonen A, Kokki H, Nuutinen J. Recovery after tonsillectomy in adults: a three-week follow-up study. Laryngoscope. 2002 Jan;112(1):94-8. doi: 10.1097/00005537-200201000-00017.

    PMID: 11802045BACKGROUND

  • Ashbach MN, Ostrower ST, Parikh SR. Tonsillectomy techniques and pain: a review of randomized controlled trials and call for standardization. ORL J Otorhinolaryngol Relat Spec. 2007;69(6):364-70. doi: 10.1159/000108369. Epub 2007 Nov 23.

    PMID: 18033974BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative HemorrhageBody Weight Changes

Interventions

oxycodone-acetaminophenHydrocodoneAcetaminophenOxycodoneHydromorphone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingHemorrhageBody Weight

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Samuel Pate, M.D.

    University of Nebraska Medical Center Department of Otolaryngology - Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

February 9, 2015

Study Start

January 1, 2016

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

US(1)