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

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05626010
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.3
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Disease	Drug: Acetaminophen; Drug: Ibuprofen	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy
• Actual Study Start Date: Nov 23, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. postoperative pain [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 Outcome Measures

1. pain killer requirement [during 30 minutes after surgery]

   the incidence of the patients who require pain killer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of	06591

Sponsors and Collaborators

• The Catholic University of Korea

Investigators

• Principal Investigator: youngeun moon, MD, PhD, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Eun Moon, professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT05626010
• Other Study ID Numbers: AAP-ibuprofen-thyroid
• First Posted: Nov 23, 2022
• Last Update Posted: Nov 25, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroid Diseases; Pain, Postoperative; Acetaminophen; Ibuprofen

Study Results

No Results Posted as of Nov 25, 2022