NCT03988075

Brief Summary

Pain control modalities were evaluated after thyroidectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 24, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 14, 2019

Last Update Submit

May 8, 2020

Conditions

PainThyroidectomy

Outcome Measures

Primary Outcomes (4)

  • visual analog scale pain level

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

    1 hour post operatively

  • visual analog scale pain level

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

    6 hour post operatively

  • visual analog scale pain level

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

    24 hour post operatively

  • visual analog scale pain level

    Pain level from 0 (no pain) to 10 (worst pain imaginable).

    7 days post operatively

Secondary Outcomes (1)

  • opioid use

    with the first 24 hours post operatively

Study Arms (2)

Acetaminophen and hydrocodone based pain control

ACTIVE COMPARATOR

Patients receive acetaminophen 650mg every 4 for pain level 1-3, hydrocodone/acetaminophen 5/325mg every 4 for pain level 4-6, or hydrocodone/acetaminophen 10/650mg every 4 for pain level 7-10 on as needed basis.

Other: Acetaminophen and hydrocodone based pain control

Acetaminophen and ibuprofen based pain control

EXPERIMENTAL

Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.

Other: Acetaminophen and ibuprofen based pain control

Interventions

Acetaminophen and hydrocodone based pain controlOTHER

Patients receive acetaminophen 650mg every 4 for pain level 1-3, hydrocodone/acetaminophen 5/325mg every 4 for pain level 4-6, or hydrocodone/acetaminophen 10/650mg every 4 for pain level 7-10 on as needed basis.

Acetaminophen and hydrocodone based pain control
Acetaminophen and ibuprofen based pain controlOTHER

Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.

Acetaminophen and ibuprofen based pain control

Eligibility Criteria

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

You may qualify if:

  • thyroid disease

You may not qualify if:

  • currently on opioid pain medications
  • on opioid pain meds in last 30 days
  • cannot take non-opioid medications
  • require more extensive operation than thyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (4)

  • Francis DO, Randolph G, Davies L. Nationwide Variation in Rates of Thyroidectomy Among US Medicare Beneficiaries. JAMA Otolaryngol Head Neck Surg. 2017 Nov 1;143(11):1122-1125. doi: 10.1001/jamaoto.2017.1746.

    PMID: 29049468RESULT

  • Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

    PMID: 28403427RESULT

  • Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

    PMID: 11222424RESULT

  • Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.

    PMID: 12095591RESULT

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Erin Felger, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized to one of two study groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

June 17, 2019

Study Start

July 24, 2018

Primary Completion

August 1, 2019

Study Completion

September 30, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

US(1)