Pharmacokinetics of Intranasal Ketorolac in Children
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 1/19/2019 |
| Start Date: | February 2015 |
| End Date: | November 29, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Daniel S Tsze, MD, MPH
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