Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Disease
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen

Detailed Description

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 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after thyroidectomy. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: youngeun moon, MD, PhD; Phone Number: 822-2258-6163; Email: 0910momo@naver.com
• Study Contact Backup: Name: jaesik park, MD; Phone Number: 822-2258-6163; Email: cmcanepm@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Seocho-gu
    • Seoul, Seocho-gu, Korea, Republic of, 06591
      • Recruiting
      • Seoul St. Mary's Hospital
      • Contact: Youngeun Moon, MD, PhD; Phone Number: 01090801020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; acetaminophen 1g iv dripping	Drug: Acetaminophen; acetaminophen 1g iv dripping at end of surgery
Experimental: experimental group; the combination of acetaminophen 1g and ibuprofen 300mg iv dripping	Drug: Acetaminophen; acetaminophen 1g iv dripping at end of surgery; Drug: Ibuprofen; ibuprofen 300mg iv dripping at end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain killer requirement	the incidence of the patients who require pain killer	during 30 minutes after surgery

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: youngeun moon, MD, PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Endocrine System Diseases; Pain, Postoperative; Thyroid Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: AAP-ibuprofen-thyroid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No