NEWS HIGHLIGHTSMedia Articles Related to Duraclon (Clonidine)
Addrenex Pharmaceuticals Files SNDA Submission For Clonicel To Treat ADHD
Source: ADHD News From Medical News Today [2009.10.04]
Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD). The submission is based on the successful completion of Phase III clinical trials demonstrating statistical significance when Clonicel was used to treat ADHD in children and adolescents.
Published Studies Related to Duraclon (Clonidine)
Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children. [2009.08]
BACKGROUND: Caudal block is a common technique for paediatric analgesia but with the disadvantage of short duration of action after single injection. Caudal dexmedetomidine and clonidine could offer significant analgesic benefits. We compared the analgesic effects and side-effects of dexmedetomidine and clonidine added to bupivacaine in paediatric patients undergoing lower abdominal surgeries... CONCLUSIONS: Addition of dexmedetomidine or clonidine to caudal bupivacaine significantly promoted analgesia in children undergoing lower abdominal surgeries with no significant advantage of dexmedetomidine over clonidine and without an increase in incidence of side-effects.
[Efficacy of clonidine transdermal patch for treatment of Tourette's syndrome in children] [2009.07]
OBJECTIVE: Children with Tourette's syndrome (TS) have a poor treatment compliance due to side effects and inconvenient administration of oral drugs. This study explored the efficacy and safety of clonidine transdermal patch for treating TS in children... CONCLUSIONS: Clonidine transdermal patch is effective for the treatment of TS in children and its side effects are mild and rare.
Nefopam and alfentanil additively reduce the shivering threshold in humans whereas nefopam and clonidine do not. [2009.07]
BACKGROUND: Induction of therapeutic hypothermia is often complicated by shivering. Nefopam reduces the shivering threshold with minimal side effects. Consequently, nefopam is an attractive component for induction of therapeutic hypothermia. However, nefopam alone is insufficient; it will thus need to be combined with another drug. Clonidine and alfentanil each reduce the shivering threshold. This study, therefore, tested the hypothesis that nefopam, combined either with clonidine or alfentanil, synergistically reduces the shivering threshold... CONCLUSIONS: Nefopam and alfentanil additively reduce the shivering threshold, but nefopam and clonidine do not.
Effects of epidural clonidine and neostigmine following intrathecal labour analgesia: a randomised, double-blind, placebo-controlled trial. [2009.07]
BACKGROUND: The limited duration of spinal labour analgesia combined with problems associated with maintenance of epidural analgesia, have prompted the search for combinations that could prolong spinal analgesia. A randomised, double-blind trial was carried out to test the hypotheses (a) that initial spinal labour analgesia is prolonged by administering clonidine and neostigmine epidurally whilst (b) the hourly local anaesthetic consumption is reduced... CONCLUSION: Epidural administration of neostigmine 500 microg and clonidine 75 microg, following the intrathecal injection of ropivacaine and sufentanil, prolongs analgesia and reduces hourly ropivacaine consumption.
Unilateral spinal anaesthesia for outpatient surgery: a comparison between hyperbaric bupivacaine and bupivacaine-clonidine combination. [2009.07]
BACKGROUND: Low-dose hyperbaric bupivacaine has been used to produce unilateral spinal anaesthesia for outpatient surgery. Unilateral spinal anaesthesia is associated with reduction of hypotension, faster recovery and increased patient satisfaction.
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.
PeriOperative ISchemic Evaluation-2 Pilot [Not yet recruiting]
Major non-cardiac surgeries are common and major heart problems during or after such
surgeries represent a large population health problem. Few treatments to prevent heart
problems around the time of surgery have been tested.
There is encouraging data suggesting that low-doses of Acetyl-Salicylic Acid (ASA) and
Clonidine, which are two medications, given individually for a short period before and after
major surgeries may prevent major heart problems.
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.
Clonidine and Morphine in Caudal Anesthesia [Recruiting]
Systematic Clonidine for Epidural Analgesia in Labour [Recruiting]
In a prospective randomised study involving primiparous women in spontaneous uncomplicated
labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial
volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual
injections to achieve analgesia, then by a patient-controlled regimen with 5-mL
self-administered boli in addition to a continuous infusion of 5 mL. hr-1. The anaesthetic
solution will be levobupivacaine presented in 100-mL bags from the market (0. 0625%), in
which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm.
The final concentration of clonidine in this arm will be 1. 35 mg. mL-1. Parturients and
midwifes assessing pain during labour will be blinded to the design.
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