Pharmacokinetics of Intranasal Ketorolac in Children

Pain Clinical Trial

Official title:

Pharmacokinetics of Intranasal Ketorolac in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02297906
• Other study ID #: AAAN5404
• Status: Terminated
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: November 29, 2017

Study information

• Verified date: January 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Evaluating Pharmacokinetics of Intranasal Ketorolac
• Pain

Intervention

Drug:
• Ketorolac
Non-steroidal anti-inflammatory drug

Locations

Country	Name	City	State
United States	New York Presbyterian Morgan Stanley Children's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of intranasal ketorolac	Maximum serum concentration of ketorolac, after intranasal administration	60 minutes
Secondary	Tmax of intranasal ketorolac	Time to maximum serum concentration of ketorolac, after intranasal administration	6 hours
Secondary	Bioavailability of intranasal ketorolac	Bioavailability of intranasal ketorolac; expressed as a percentage (numerator = serum levels achieved by intranasal administration, denominator = serum levels achieved by intravenous administration)	6 hours