Clinical trial NCT02297906: Pharmacokinetics of Intranasal Ketorolac in Children
Official title: Pharmacokinetics of Intranasal Ketorolac in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Evaluating Pharmacokinetics of Intranasal Ketorolac
Pain
Keywords: Intranasal
Ketorolac
Pharmacokinetics
Pediatric
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cmax of intranasal ketorolac
timeFrame: 60 minutes
Secondary outcomes:
measure: Tmax of intranasal ketorolac
timeFrame: 6 hours
measure: Bioavailability of intranasal ketorolac
timeFrame: 6 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Morgan Stanley Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Daniel S Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: