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

Overview

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 Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: November 2023

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

Interventions

• Drug: Acetaminophen
  • acetaminophen 1g iv dripping at end of surgery
• Drug: Ibuprofen
  • ibuprofen 300mg iv dripping at end of surgery

Arms, Groups and Cohorts

• Active Comparator: control group
  • acetaminophen 1g iv dripping
• Experimental: experimental group
  • the combination of acetaminophen 1g and ibuprofen 300mg iv dripping

Clinical Trial Outcome Measures

Primary Measures

• postoperative pain
  • Time Frame: during 30 minutes after surgery
  • the maximal postoperative pain severity using pain scale(visual analogue scale; 0 cm=no pain; 10 cm=the worst pain)

Secondary Measures

• pain killer requirement
  • Time Frame: during 30 minutes after surgery
  • the incidence of the patients who require pain killer

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • The Catholic University of Korea
• Provider of Information About this Clinical Study
  • Principal Investigator: Young Eun Moon, professor – The Catholic University of Korea
• Overall Official(s)
  • youngeun moon, MD, PhD, Principal Investigator, Seoul St. Mary’s Hospital
• Overall Contact(s)
  • youngeun moon, MD, PhD, 822-2258-6163, 0910momo@naver.com