Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Otolaryngology |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 7/20/2017 |
| Start Date: | May 2004 |
| End Date: | June 2009 |
The Optimal Dose of Prophylactic Naloxone in Ameliorating Opioid Induced Side Effects in Children and Adolescents Receiving Intravenous Patient Controlled Analgesia (IVPCA) Morphine for Moderate to Severe Pain: A Pharmacodynamic, Pharmacokinetic, and Pharmacogenetic Study
This is an investigator initiated dose finding study designed to determine the optimal dose
of naloxone to prevent or minimize the most common side effects induced by opioids, namely
itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the
Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,
moderate to severe pain, and who are to be treated with intravenous Patient controlled
analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be
recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of
patients will be post operative patients, and will start therapy and the investigational drug
in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan
on studying between 10 and 99, male and female patients over a 2 year period.
of naloxone to prevent or minimize the most common side effects induced by opioids, namely
itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the
Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,
moderate to severe pain, and who are to be treated with intravenous Patient controlled
analgesia (IVPCA) morphine will be eligible for inclusion in this study. Patients will be
recruited by a study investigator prior to the initiation of IVPCA therapy. The majority of
patients will be post operative patients, and will start therapy and the investigational drug
in the Post Anesthesia Care Unit or the Pediatric Intensive Care Unit. The investigators plan
on studying between 10 and 99, male and female patients over a 2 year period.
In patients of all ages, opioids are the cornerstone of management of moderate to severe
pain. Regardless of method of administration, all opioids produce unwanted side effects,
including pruritus, nausea and vomiting, constipation, urinary retention, cognitive
impairment, tolerance, dependence, and (rarely) respiratory depression. Based on the results
of a previously completed randomized controlled trial, children and adolescents with moderate
to severe pain, are now routinely treated in the Children's Center of the Johns Hopkins
Hospital with a low dose naloxone infusion (0.25 mcg/kg/HOUR) whenever morphine intravenous
patient controlled analgesia (IVPCA) or parent/nurse controlled analgesia (IVPNCA) is
initiated. Although the previous study showed a marked reduction in the incidence and
severity of pruritus and nausea, approximately a third of the patients still experience these
side effects. The primary purpose of this study is to reduce this failure rate by determining
if there is an optimal dose of naloxone to prevent opioid induced side effects as determined
by a dose finding classic up down dose escalation method. The second aim is to determine the
pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone
infusion rates attempted. The investigators will measure morphine, naloxone, and their
metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric
method (LC/MS/MS). The final aim is to determine the pharmacogenetics of responders and
non-responders using DNA isolated from patient blood. To accomplish this the investigators
will need a single blood collection from patients currently being treated with IVPCA morphine
and low dose intravenous naloxone.
pain. Regardless of method of administration, all opioids produce unwanted side effects,
including pruritus, nausea and vomiting, constipation, urinary retention, cognitive
impairment, tolerance, dependence, and (rarely) respiratory depression. Based on the results
of a previously completed randomized controlled trial, children and adolescents with moderate
to severe pain, are now routinely treated in the Children's Center of the Johns Hopkins
Hospital with a low dose naloxone infusion (0.25 mcg/kg/HOUR) whenever morphine intravenous
patient controlled analgesia (IVPCA) or parent/nurse controlled analgesia (IVPNCA) is
initiated. Although the previous study showed a marked reduction in the incidence and
severity of pruritus and nausea, approximately a third of the patients still experience these
side effects. The primary purpose of this study is to reduce this failure rate by determining
if there is an optimal dose of naloxone to prevent opioid induced side effects as determined
by a dose finding classic up down dose escalation method. The second aim is to determine the
pharmacokinetics of morphine and naloxone and their metabolites at each of the naloxone
infusion rates attempted. The investigators will measure morphine, naloxone, and their
metabolites using a liquid chromatographic-electrospray ionization-tandem mass spectrometric
method (LC/MS/MS). The final aim is to determine the pharmacogenetics of responders and
non-responders using DNA isolated from patient blood. To accomplish this the investigators
will need a single blood collection from patients currently being treated with IVPCA morphine
and low dose intravenous naloxone.
Inclusion Criteria:
- Male and female patients greater than 6 and less than 18 years of age with acute,
moderate to severe pain who are to start treatment with IVPCA morphine as inpatients
of the Children's Center of the Johns Hopkins Hospital
Exclusion Criteria:
- patients who require concomitant benzodiazepine administration
- allergic to opioids
- have been in an investigational drug trial within 1 month
- received opioids with in 7 days of the study
- parent with psychiatric illness which impairs their ability to provide consent parent
who does not speak English
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