NCT05626010

Brief Summary

Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after thyroidectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

November 15, 2022

Last Update Submit

November 23, 2022

Conditions

Thyroid Disease

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    the maximal postoperative pain severity using pain scale(visual analogue scale; 0 cm=no pain; 10 cm=the worst pain)

    during 30 minutes after surgery

Secondary Outcomes (1)

  • pain killer requirement

    during 30 minutes after surgery

Study Arms (2)

control group

ACTIVE COMPARATOR

acetaminophen 1g iv dripping

Drug: Acetaminophen

experimental group

EXPERIMENTAL

the combination of acetaminophen 1g and ibuprofen 300mg iv dripping

Drug: AcetaminophenDrug: Ibuprofen

Interventions

AcetaminophenDRUG

acetaminophen 1g iv dripping at end of surgery

control groupexperimental group
IbuprofenDRUG

ibuprofen 300mg iv dripping at end of surgery

experimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patients undergoing scheduled thyroidectomy
  • American Society of Anesthesiologists status 1 or 2

You may not qualify if:

  • refusal to be enrolled in the study
  • emergency surgery
  • hepatic or renal disease
  • on chronic pain medications
  • psychiatric disorders
  • pregnancy, lactation
  • allergy or contraindication to the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • youngeun moon, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

youngeun moon, MD, PhD

CONTACT

822-2258-61630910momo@naver.com

jaesik park, MD

CONTACT

822-2258-6163cmcanepm@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

November 23, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)