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Painkiller study for newborns pulled before it started

NCT ID NCT01667120

Symptom relief Sponsor: Nationwide Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test whether the painkiller ketorolac is safe and effective for newborns (up to 3 months old) after abdominal surgery. Researchers wanted to compare bleeding and pain control between babies given the drug and those given a placebo. However, the study was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jul 2012

An estimate. Start dates often move.

Finished

Dec 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 week to 3 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Infants gestational age \> 37 weeks and greater than or equal to one week of age to 3 months of age 2. Infants who are undergoing a surgical procedure on the abdomen 3. the parent or guardian has given informed consent. Exclusion Criteria: 1. Gestational age \< 37 weeks 2. Age less than one week or greater than 3 months of age 3. Known renal disease/dysplastic kidneys 4. Serum Creatinine \> 0.4 5. Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline) 6. Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa \[except for use of thrombosed central venous catheters\], enalapril, systemic heparin \[except for use in central venous catheter flushes\]) 7. Patients who undergo nephrectomy 8. Patients with necrotizing enterocolitis 9. Patients with a hemoglobin value \< 10g/dL 10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation 11. Platelet count \< 50,000 12. Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage 13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA) 14. Allergy to ASA or other NSAIDS

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postoperative pain control in surgical neonates

Contacts and locations

Locations

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States