Pyloric StenosisNCT02359305

Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy

An observational study of Pyloric Stenosis, run by Arlyne Thung at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Pyloric Stenosis
What is being tested?: Acetaminophen
Type of treatment: Injection or infusion
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Aug 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who presented for pyloromyotomy

Who may be able to join

patients who presented for pyloromyotomy

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.

Conditions: Pyloric Stenosis
Being tested: Acetaminophen
Medical subject headings: Pyloric Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetaminophenDrug
Also called Ofirmev
Acetaminophen given by IV
AcetaminophenDrug
Also called Acephen, Feverall
Acetaminophen suppository given rectally

Study groups in NCT02359305
Study group	Role	What they receive
IV Acetaminophen		Acetaminophen administered by intravenous infusion. Receives: Drug: Acetaminophen
Rectal Acetaminophen		Acetaminophen administered by rectal suppository. Receives: Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

Acetaminophen Dosage
One time in the OR prior to the start of surgery
Measured: Baseline
Average FLACC Pain Score in the PACU
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.
Measured: 0-60 minutes post-operatively

Secondary outcomes (1)

PACU Time
Time spent in the post-anesthesia care unit post-operatively.
Measured: 45-60 minutes post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Aug 2016

First posted10 Feb 2015 (estimated)
Study startJun 2014
Primary completionJul 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pyloric StenosisStudies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02359305
Sponsor's protocol ID: IRB14-00149
Status last verified: Apr 2017
First submitted: 31 Jul 2014
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy
ClinicalTrials.gov ID: NCT02359305
Acronym / sponsor ID: IRB14-00149
Conditions: Pyloric Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Arlyne ThungUniversity, hospital or other
Study start: Jun 2014 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 10 Feb 2015 (estimated)
Results: Posted 5 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
IV Acetaminophen	–	Drug: AcetaminophenAcetaminophen administered by intravenous infusion.
Rectal Acetaminophen	–	Drug: AcetaminophenAcetaminophen administered by rectal suppository.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who presented for pyloromyotomy

Key inclusion criteria (1 listed)

patients who presented for pyloromyotomy

Key exclusion criteria (1 listed)

none

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
AcetaminophenAlso: OfirmevAcetaminophen given by IV	Drug	IV Acetaminophen
AcetaminophenAlso: Acephen, FeverallAcetaminophen suppository given rectally	Drug	Rectal Acetaminophen

Primary outcome

Acetaminophen Dosage
Time frame: Baseline
One time in the OR prior to the start of surgery
Average FLACC Pain Score in the PACU
Time frame: 0-60 minutes post-operatively
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.

1 secondary outcome

PACU Time
Time frame: 45-60 minutes post-operatively

Results and safety

Results posted to the registry on 5 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Acetaminophen	34	34
Rectal Acetaminophen	34	34

Primary outcome: Acetaminophen Dosage

Time frame: Baseline. Mean (Standard Deviation). Unit: mg/kg

Measure	IV Acetaminophen n = 34	Rectal Acetaminophen n = 34
Value	8.6 (3.9)	30.7 (6.3)

Primary outcome: Average FLACC Pain Score in the PACU

Time frame: 0-60 minutes post-operatively. Mean (Standard Deviation). Unit: units on a scale 0-10

Measure	IV Acetaminophen n = 34	Rectal Acetaminophen n = 34
Value	0.3 (0.6)	0.6 (1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During hospital stay following surgery (average 1-3 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Acetaminophen	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Rectal Acetaminophen	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pyloric Stenosis, run by Arlyne Thung 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Feb 2018. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acetaminophen Dosage (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT02359305.

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 5 Feb 2018.