Postoperative PainNCT04662567
Oral Versus Intravenous Acetaminophen for Postoperative Pain Control
A study testing acetaminophen in people with Postoperative Pain and IVF, run by Northwell Health at 1 site in United States.
Trial summary
The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, IVF
- What is being tested?
- acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 5 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Fertility Center #3816
Manhasset, New York, 11030
About this study
Official title: Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial
The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen
Read the detailed description
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
- Postoperative Pain, IVF
- Being tested
- acetaminophen
- Keywords
- oocyte retrieval, postoperative pain control, in vitro fertilization, tylenol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
compare the postoperative pain 1 hour and ~24h post surgery
| Study group | Role | What they receive |
|---|---|---|
| Oral acetaminophen group | Active comparator | the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval Receives: Drug: acetaminophen |
| IV acetaminophen group | Active comparator | the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively Receives: Drug: acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-48 hours
Secondary outcomes (1)
Duration of postoperative recovery
To compare time from the end of procedure until discharge. This outcome is measured in minutes from the the time of entry to recovery room to the time when patient is leaving the facility
Measured: variable ~1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start12 Mar 2021
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Why it stopped: It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Mullin, MD, Principal investigator, Northwell Health OBGYN Infertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662567
- Sponsor's protocol ID
- 20-1139
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the individual participant data will not be shared
Publications
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.
PubMed 12044794Flower 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.
PubMed 4564318Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.
PubMed 15662292Hinz 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.
PubMed 22039164Hinz 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.
PubMed 17884974Hinz 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.
PubMed 16385545Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010 Dec;28(4):619-45. doi: 10.1016/j.anclin.2010.08.006.
PubMed 21074742Moller 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.
PubMed 15790675Nakamura 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.
PubMed 11274793Pasero 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.
PubMed 22652283Pickering 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.
PubMed 17957182Pickering 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.
PubMed 16580905
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04662567
- Acronym / sponsor ID
- 20-1139
- Conditions
- Postoperative Pain, IVF
- Keywords
- oocyte retrieval, postoperative pain control, in vitro fertilization, tylenol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral acetaminophen group | Active comparator | Drug: acetaminophenthe subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval |
| IV acetaminophen group | Active comparator | Drug: acetaminophenthe subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophencompare the postoperative pain 1 hour and ~24h post surgery | Drug | IV acetaminophen group, Oral acetaminophen group |
Primary outcome
postoperative pain control
Time frame: 24-48 hours
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.
1 secondary outcome
Duration of postoperative recovery
Time frame: variable ~1-3 hours
Results and safety
The study was stopped early (reason given: It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 12044794Alloui 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.
- Background: PubMed 4564318Flower 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.
- Background: PubMed 15662292Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.
- Background: PubMed 22039164Hinz 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.
- Background: PubMed 17884974Hinz 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.
- Background: PubMed 16385545Hinz 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.
- Background: PubMed 21074742Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010 Dec;28(4):619-45. doi: 10.1016/j.anclin.2010.08.006.
- Background: PubMed 15790675Moller 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.
- Background: PubMed 11274793Nakamura 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.
- Background: PubMed 22652283Pasero 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.
- Background: PubMed 17957182Pickering 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.
- Background: PubMed 16580905Pickering 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.
- Individual participant dataSharing planned: No. the individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Mullin, MD principal investigator
Northwell Health OBGYN Infertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetaminophen in people with Postoperative Pain and IVF, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain control (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662567, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.