Pharmacokinetics of Intranasal Ketorolac in Children

Condition(s) targeted: Evaluating Pharmacokinetics of Intranasal Ketorolac; Pain

Intervention: Ketorolac (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Daniel S Tsze, MD, MPH, Principal Investigator, Affiliation: Columbia University

Overall contact:
Daniel S Tsze, MD, MPH, Phone: 212-305-9825, Email: dst2141@columbia.edu

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.

Official title: Pharmacokinetics of Intranasal Ketorolac in Children

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cmax of intranasal ketorolac

Secondary outcome:

Tmax of intranasal ketorolac

Bioavailability of intranasal ketorolac

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.

Minimum age: 8 Years. Maximum age: 17 Years. Gender(s): Both.

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

Daniel S Tsze, MD, MPH, Phone: 212-305-9825, Email: dst2141@columbia.edu

New York Presbyterian Morgan Stanley Children's Hospital, New York, New York 10032, United States; Recruiting
Daniel S Tsze, MD, MPH, Principal Investigator
Peter S Dayan, MD, MSc, Sub-Investigator
Serge Cremers, PharmD, PhD, Sub-Investigator

Starting date: February 2015
Last updated: February 2, 2015