Duraclon (Clonidine Hydrochloride) - Summary

DURACLON SUMMARY

Duraclon (clonidine hydrochloride injection) is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride, USP, is an imidazoline derivative and exists as a mesomeric compound.

Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials).

The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS).

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NEWS HIGHLIGHTS

Published Studies Related to Duraclon (Clonidine)

Clonidine Maintenance Prolongs Opioid Abstinence and Decouples Stress From Craving in Daily Life: A Randomized Controlled Trial With Ecological Momentary Assessment. [2015]
CONCLUSIONS: Clonidine, a readily available medication, is useful in opioid

A randomized feasibility trial of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockade: the EPIC study. [2014]
chronic beta-blockade... CONCLUSION: This pilot randomized trial confirmed the feasibility, safety, and

Effect of oral low dose clonidine premedication on postoperative pain in patients undergoing abdominal hysterectomy: a randomized placebo controlled clinical trial. [2013]
CONCLUSION: A single oral 100 microg dose of clonidine administered 2 hours

Prophylactic midazolam and clonidine for emergence from agitation in children after emergence from sevoflurane anesthesia: a meta-analysis. [2013]
sevoflurane anesthesia... CONCLUSIONS: This meta-analysis suggests that prophylactic administration of

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...

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Clinical Trials Related to Duraclon (Clonidine)

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia [Not yet recruiting]
This research is being done to find out the safety of the investigational study drug,clonidine, in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). HIE is the damage that occurs to the cells of the central nervous system (brain and spinal cord) as a result of decreased oxygen supply and blood flow to the fetus due to perinatal asphyxia (inadequate oxygen to the baby during the birth process). HIE is a significant cause of morbidity and mortality in infants. The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process babies get agitated, shiver and are uncomfortable. To treat these side effects sedative-analgesic medications like morphine are frequently used. Clonidine (Clon), which is another class of sedative-analgesic can be used for the similar purpose but is more effective than morphine in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury). Clon (Duraclon®) has been approved by the Food and Drug Administration (FDA)for the treatment of pain in certain cancer patients. It is not approved for treating side effects of therapeutic hypothermia in infants and its use in this study is considered investigational. FDA is allowing for us to use clonidine for this Phase I-II study. In this kind of study clonidine will be started at low dose and slowly increased do determine at what dose the shivering is controlled and the use of clonidine is not associated with any side effects. This means that not all babies in the study will get the same dose of Clon. Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some babies may get doses that are too low to have an effect, and other babies will probably might get a doses that could cause side effects. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of clonidine during cooling for HIE, (ii) the effects of clonidine on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow in the face of blood pressure changes) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure [Completed]
The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain [Recruiting]
Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patient will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal if any effect on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers [Completed]
To establish the bioequivalence and adhesion properties of transdermal clonidine prepared with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination [Not yet recruiting]
Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity of pain and effective postoperative analgesia is necessary for optimal recovery. Single injections ultrasound guided rectus sheath blocks provide satisfactory postoperative analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching for a blocking agent that last long enough to outlast pain and has minimal side effects is a difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but anxiolytic properties of clonidine were not investigated. This study will compare rectus sheath ropivacaine blocks with ropivacaine and clonidine blocks. Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be double blinded and randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0. 5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive ropivacaine 0. 5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed. The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic site, reduces the need for analgesics, improves satisfaction with pain control, and is associated with complications such as oversedation, hypotension, and bradycardia. Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by at least 50% is clinical relevant. The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine offer improved pain management compared to ropivacaine alone.

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