Pharmacokinetics of Intranasal Ketorolac in Children

NCT ID: NCT02297906

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-11-29

Brief Summary

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.

Detailed Description

The intranasal (IN) route of administering medications is an effective means of delivering analgesics to children in a painless and minimally distressing manner, especially in comparison to traditional means of intravenous (IV) or intramuscular (IM) administration, which require a painful and distressing needle stick.

Ketorolac is an analgesic that is commonly administered to children, and can be given by the IN route, in addition to the IV and IM routes. However, the pharmacokinetics of intranasal ketorolac when administered in children has only been described in a limited fashion. The administration of IN ketorolac in children, using the proprietary SPRIX device, which atomizes a fixed amount of ketorolac, produces serum concentrations of ketorolac that are associated with analgesia. However, the concentrations of ketorolac achieved using a mucosal atomization device (MAD) has not yet been evaluated in children presenting to the emergency department. The MAD is a plastic device that attaches to the top of a syringe (see figure). The MAD is much more commonly used for atomizing medications; allows a variable dosage to be administered; and has been shown to be a means of effectively delivering other analgesics and sedatives intranasally.

The purpose of this study is to assess the pharmacokinetics of IN ketorolac when using a MAD to deliver the medication in children presenting to the emergency department. We will determine the maximum serum concentration achieved (Cmax), time to maximum serum concentration achieved (Tmax), and bioavailability (compared to IV ketorolac) when ketorolac is administered intranasally using a MAD.

Conditions

Evaluating Pharmacokinetics of Intranasal Ketorolac; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal ketorolac

Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intranasal route using a mucosal atomization device.

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Non-steroidal anti-inflammatory drug

Intravenous ketorolac

Ketorolac 0.5 mg/kg, maximum single dose = 30 mg. Administered once by intravenous route.

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

Non-steroidal anti-inflammatory drug

Interventions

Ketorolac

Non-steroidal anti-inflammatory drug

Intervention Type: DRUG

Other Intervention Names

Toradol

Eligibility Criteria

Inclusion Criteria

• Present to the emergency department with a painful condition for which the treating physician decides to administer ketorolac as part of their usual care.

Exclusion Criteria

• Known allergy to ketorolac
• Contraindication to receiving ketorolac
• Receiving any NSAID within the past 6 hours
• Presence of an intranasal obstruction that cannot be readily cleared using suction or nose-blowing
• Inability to speak English or Spanish
• Critical illness

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S Tsze, MD, MPH

Assistant Professor of Pediatrics at CUMC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S Tsze, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States

Countries

United States

Other Identifiers

AAAN5404

Identifier Type: -

Identifier Source: org_study_id