NCT01667120

The Use of Ketorolac in Surgical Neonates

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Week – 3 Months
• Healthy volunteers: Not accepted

Summary

The general purpose of this study is to characterize the safety profile of ketorolac in infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9% normal saline as placebo. Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that ketorolac is safe and effective in infants \> 37wks gestation and at least one week of age. Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.

Detailed description

This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients one week of age to 3 months of age who undergo an abdominal surgical procedure within the moderate or severe degree of pain category (see attached Table 1: postoperative pain categories) will be randomized to receive standard pain management regimens plus placebo (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain management regimens. The postoperative management will be unchanged and at the discretion of the attending surgeon, as appropriate for the surgical procedure. The patients will be followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary endpoints.

Conditions

• Postoperative Pain Control in Surgical Neonates

Interventions

Type	Name	Description
DRUG	Ketorolac	Ketorolac 0.5mg/kg IV q8h x 72h.
DRUG	placebo	0.9% normal saline 1ml/kg

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2012-08-17
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States