NEWS HIGHLIGHTS
Published Studies Related to Duraclon (Clonidine)
Clonidine improved laboratory-measured decision-making performance in abstinent
heroin addicts. [2012]
BACKGROUND: Impulsivity refers to a wide spectrum of actions characterized by
quick and nonplanned reactions to external and internal stimuli, without taking
into account the possible negative consequences for the individual or others, and
decision-making is one of the biologically dissociated impulsive behaviors...
The combination very low-dose naltrexone-clonidine in the management of opioid
withdrawal. [2012]
BACKGROUND: The management of withdrawal absorbs substantial clinical efforts in
opioid dependence (OD)... CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Preliminary results elucidate
neurobiological mechanisms of OD and support the utility of controlled studies on
a novel VLNTX + low-dose clonidine combination for the management of opioid
withdrawal.
Management of hot flashes in patients who have breast cancer with venlafaxine and clonidine: a randomized, double-blind, placebo-controlled trial. [2011.10.10]
PURPOSE: Therapies for breast cancer may induce hot flashes that can affect quality of life. We undertook a double-blind, placebo-controlled trial with the primary objective of comparing the average daily hot flash scores in the twelfth week among patients treated with venlafaxine, clonidine, and placebo. Additional analyses of the hot flash score over the full 12 weeks of treatment were performed... CONCLUSION: Venlafaxine and clonidine are effective treatments in the management of hot flashes in patients with breast cancer. Venlafaxine resulted in a more immediate reduction of hot flash scores when compared with clonidine; however, hot flash scores at week 12 were lower in the clonidine group than in the venlafaxine group.
Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labour. [2011.09]
We studied the potentiation of analgesia for labour by the addition of clonidine to epidural low-concentration levobupivacaine with sufentanil in a randomised, double-blinded study. We enrolled primiparous women who were in spontaneous labour...
Supplementation of retrobulbar block with clonidine in vitreoretinal surgery: effect on postoperative pain. [2011.08]
STUDY OBJECTIVE: To evaluate the effect of clonidine when added to local anesthetics on duration of postoperative analgesia during retrobulbar block... CONCLUSIONS: The addition of clonidine 0.5 mug/kg to the local anesthetics of a retrobulbar block for vitreoretinal surgery decreases the frequency of postoperative pain and prolongs the time of analgesia. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Clinical Trials Related to Duraclon (Clonidine)
Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor [Not yet recruiting]
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor
pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along
with an opioid, e. g., our common "recipe" of 12 ml/hr of 0. 0625% bupivacaine with 2
micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery.
This dose of the infusion often provides adequate comfort without interfering with the
mobility of the patient and her ability to effectively push during delivery. However, this
low dose epidural infusion strategy often results in recurrence of pain after an initial
pain free period.
This breakthrough pain is treated by administering small boluses of analgesics via the
epidural catheter. The pain occurring in labor is initially of visceral origin and is
mediated by pain fibers originating from the low thoracic and upper lumbar segments of the
spinal cord. As labor progresses to the late first phase (also known as transitional stage),
pain sensations originating from the distension of the pelvic floor, vagina and perineum
adds a somatic component to labor pain. This type of breakthrough pain is often difficult to
treat.
Although requests from patients to alleviate late stage breakthrough pain are common, no one
knows the most effective strategy for pain management in this stage of labor. This study is
designed to compare the efficacy of two treatments for controlling late first stage
breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine
versus fentanyl-bupivacaine.
Women who have labor epidural analgesia in place will be enrolled to be randomized if and
when they present with breakthrough pain in the late first stage or second stage of labor
(≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75
micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist
known to be effective as an epidural analgesic).
Pain relief, labor progress and outcome will be assessed to compare fentanyl versus
clonidine.
It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic
than fentanyl added to bupivacaine for breakthrough pain in advanced labor.
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants [Not yet recruiting]
Thousands of critically ill infants (and children) are exposed to opioids and
benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and
pediatric intensive care units. While the use of these agents are undisputedly beneficial in
reducing pain and anxiety, improving ventilation, reducing pulmonary vascular resistance
and improving outcomes; the consequence is often the development of tolerance and
physiologic dependence - similar to prenatal exposure from these same classes of drugs. The
investigators have recently reported the results of randomized placebo control trial showing
that the addition of clonidine (central alpha 2 agonist) to tapering doses of opioids was
efficacious and safe in treating opioid dependence in infants who had moderate to severe
neonatal abstinence syndrome from prenatal drug exposure to opioids. Currently, the
investigators propose to perform a double-blind, randomized placebo control trial in a
cohort of critically ill infants without prenatal drug exposure at Johns Hopkins Hospital to
test the overall hypothesis that early addition of clonidine to a cohort of critically ill
neonates on mechanical ventilation who are receiving opioids and benzodiazepines for
analgesia and sedation will be efficacious and safe in reducing both the incidence and
severity of withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete
sedative and analgesic drug detoxification. The hypothesis will be tested by addressing 2
specific aims that will determine: 1) the efficacy and safety of clonidine in critically ill
infants, and 2) pharmacokinetics and pharmacodynamics using population-based
pharmacokinetics in this vulnerable infant population who have only been exposed to these
drugs as part of their routine care. Many "standard of care practices" are incorporated in
neonatal and pediatric care prior to evidence based studies. This proposal will fill a much
needed gap in translating what the investigators have learned about basic mechanisms
mediating dependence and withdrawal to proven therapies for vulnerable pediatric
populations.
Use of Transdermal Clonidine in Trauma Patients [Recruiting]
This study will attempt to learn how to better treat trauma patients with delirium who are
on a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a
common reason why ventilated patients can not be weaned from the breathing machine even
though their lungs may be healthy enough to breathe without the machine. The study hopes to
show that by decreasing the patient's delirium it will lead to quicker weaning from the
breathing machine and possibly a quicker overall recovery as well. Patients enrolled in this
study will be treated with Clonidine or placebo. Clonidine is a drug that produces
significant calming effects, decreases anxiety, and reduces pain, but with a lower incidence
of delirium than other medications used in the ICU for this purpose. Clonidine is not
approved by the Federal Food and Drug Administration for treatment of delirium, but is
commonly used for this purpose.
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children [Recruiting]
Some of the children who suffer acute burn injury do not have adequate pain and anxiety
management with the current regimen of scheduled opiates (morphine) and benzodiazepines
(lorazepam). Other children have significant side effects or contraindications, such as
constipation or over sedation, when taking these medications. Clonidine is known to reduce
the need for morphine in the management of postoperative pain. The addition of clonidine to
the pharmacological treatment of burn wound pain offers a possible adjunct to the standard
opiate and benzodiazepines regimen. Clonidine has been used in children in both on a
short-term basis (such as postoperative pain management) and on a long-term basis (such as
the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the
hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to
the management of pain and anxiety in the acutely burned child. All children will be
treated by protocol with morphine (0. 03mg/kilo) q4hr prn pain and lorazepam (0. 03 mg/kilo)
q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be
randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using
standard instruments blind to the medication being used on a daily basis Also the total
dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be
recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose
will be compared between the placebo and clonidine groups with a Student's t test. Once the
blind is broken the child will be allowed to remain on the clonidine if it is beneficial.
The second year of the grant will expand the age groups down to younger children and also
begin to gain information about the effect of clonidine on the hypermetabolic state
secondary to burn injury.
Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA) [Recruiting]
The purpose of this study is to determinate the effect of a pre-treatment with centrally
acting alpha2-receptor agonist clonidine on the pharmacodynamics and pharmacokinetics of
3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The investigators hypothesize that
clonidine will attenuate the subjective and cardiovascular response to MDMA.
|
