Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

NCT ID: NCT04662567

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2021-09-05

Brief Summary

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

Detailed Description

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Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations

Conditions

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Postoperative Pain IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Oral acetaminophen group

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

Group Type ACTIVE_COMPARATOR

acetaminophen

Intervention Type DRUG

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

IV acetaminophen group

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

Group Type ACTIVE_COMPARATOR

acetaminophen

Intervention Type DRUG

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

Interventions

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acetaminophen

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Known clinically significant liver disfunction
2. Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other
3. Known current substance use disorder
4. Chronic pain syndrome
5. Weight less than 50 kg
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Mullin, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health OBGYN Infertility

Locations

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Northwell Fertility Center #3816

Manhasset, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12044794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4564318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15662292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22039164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17884974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16385545 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21074742 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15790675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11274793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22652283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17957182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16580905 (View on PubMed)

Other Identifiers

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20-1139

Identifier Type: -

Identifier Source: org_study_id

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