Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

NCT04662567 | Terminated DMC

• 1 other identifier: 20-1139
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen

Conditions

Postoperative Pain; IVF

Keywords

oocyte retrieval; postoperative pain control; in vitro fertilization; tylenol

Outcome Measures

Primary Outcomes (1)

• postoperative pain control

  To compare the efficacy of oral versus IV formulation of acetaminophen for controlling perioperative pain after oocyte retrieval procedure. To assess the pain level, Visual Analog Scale(VAS) score will be utilize with the minimum number 0 representing no pain and maximum number of 10 representing the highest imaginable pain level.

  24-48 hours

Secondary Outcomes (1)

• Duration of postoperative recovery

  variable ~1-3 hours

Study Arms (2)

Oral acetaminophen group

ACTIVE COMPARATOR

the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval

Drug: acetaminophen

IV acetaminophen group

ACTIVE COMPARATOR

the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively

Drug: acetaminophen

Interventions

acetaminophen DRUG

compare the postoperative pain 1 hour and \~24h post surgery

IV acetaminophen group; Oral acetaminophen group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female, aged 18-45
• Ability to take oral medication and be willing to adhere to the study intervention regimen

You may not qualify if:

• Known clinically significant liver disfunction
• Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other
• Known current substance use disorder
• Chronic pain syndrome
• Weight less than 50 kg

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Fertility Center #3816

Manhasset, New York, 11030, United States

Location

Related Publications (12)

• Alloui A, Chassaing C, Schmidt J, Ardid D, Dubray C, Cloarec A, Eschalier A. Paracetamol exerts a spinal, tropisetron-reversible, antinociceptive effect in an inflammatory pain model in rats. Eur J Pharmacol. 2002 May 17;443(1-3):71-7. doi: 10.1016/s0014-2999(02)01578-9.

  PMID: 12044794 BACKGROUND

• Flower RJ, Vane JR. Inhibition of prostaglandin synthetase in brain explains the anti-pyretic activity of paracetamol (4-acetamidophenol). Nature. 1972 Dec 15;240(5381):410-1. doi: 10.1038/240410a0. No abstract available.

  PMID: 4564318 BACKGROUND

• Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.

  PMID: 15662292 BACKGROUND

• Hinz B, Brune K. Paracetamol and cyclooxygenase inhibition: is there a cause for concern? Ann Rheum Dis. 2012 Jan;71(1):20-5. doi: 10.1136/ard.2011.200087. Epub 2011 Oct 28.

  PMID: 22039164 BACKGROUND

• Hinz B, Cheremina O, Brune K. Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man. FASEB J. 2008 Feb;22(2):383-90. doi: 10.1096/fj.07-8506com. Epub 2007 Sep 20.

  PMID: 17884974 BACKGROUND

• Hinz B, Dormann H, Brune K. More pronounced inhibition of cyclooxygenase 2, increase in blood pressure, and reduction of heart rate by treatment with diclofenac compared with celecoxib and rofecoxib. Arthritis Rheum. 2006 Jan;54(1):282-91. doi: 10.1002/art.21540.

  PMID: 16385545 BACKGROUND

• Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010 Dec;28(4):619-45. doi: 10.1016/j.anclin.2010.08.006.

  PMID: 21074742 BACKGROUND

• Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.

  PMID: 15790675 BACKGROUND

• Nakamura K, Li YQ, Kaneko T, Katoh H, Negishi M. Prostaglandin EP3 receptor protein in serotonin and catecholamine cell groups: a double immunofluorescence study in the rat brain. Neuroscience. 2001;103(3):763-75. doi: 10.1016/s0306-4522(01)00027-6.

  PMID: 11274793 BACKGROUND

• Pasero C, Stannard D. The role of intravenous acetaminophen in acute pain management: a case-illustrated review. Pain Manag Nurs. 2012 Jun;13(2):107-24. doi: 10.1016/j.pmn.2012.03.002.

  PMID: 22652283 BACKGROUND

• Pickering G, Esteve V, Loriot MA, Eschalier A, Dubray C. Acetaminophen reinforces descending inhibitory pain pathways. Clin Pharmacol Ther. 2008 Jul;84(1):47-51. doi: 10.1038/sj.clpt.6100403. Epub 2007 Oct 24.

  PMID: 17957182 BACKGROUND

• Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.

  PMID: 16580905 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christine Mullin, MD

  Northwell Health OBGYN Infertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 10, 2020
• Study Start: March 12, 2021
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)