NeuroTalk Support Groups

NeuroTalk Support Groups (https://www.neurotalk.org/)

- Reflex Sympathetic Dystrophy (RSD and CRPS) (https://www.neurotalk.org/reflex-sympathetic-dystrophy-rsd-and-crps-/)

- - RSD in eyes? (https://www.neurotalk.org/reflex-sympathetic-dystrophy-rsd-and-crps-/127148-rsd-eyes.html)

Hi all,

As you know it is my 17 year old daughter that has RSD, she is in severe pain right now, she thinks the RSD is in her eyes and ears, has anyone ever had an issue with this type of spread and if so what have you done to help? Thanks all and my prayers are with all of you.

:hug:
Sandy

I had my wisdom teeth out and my rsd spread to my mouth and my ear and eyes are in so much pain as well. It is so painful I know how she is feeling. I have put a heat pack a soft one i got from Origins or the company is Dreamtime Inc, you can google it. It is the best heatpack I have found. I put it on top of my head as well and it just relaxes my eyes. It hurts to even wear sunglasses on my face because my head hurts but the sun hurts my eyes. Ever since I had my teeth out which has been about a month and a half I have had it in my eyes and ear. The heatpack is the only thing that relieved my pain a little bit. I feel for her, I know exactly what she is feeling.

Hi Hannah,

I am sorry you are still in so much pain from your wisdom teeth extraction. That is such a shame. I am going to take her into the doctor because she is taking cymbalta and another medication that can cause eye pain. She has a little yellowing in her eyes so I am very concerned right now. I have a call into her doctor as well as an email. I hope your pain gets better. What are they doing for you? Have you tried hyperbarics yet? We are going to try this for her. I have a call into a place here in Florida it is in clearwater, about 45 minutes from our house. She doesn't want to try Ketamine again. So I don't know where else to go for her.

:hug:Sandy

Quote:

Originally Posted by hannah1234 (Post 672239)

Oh yes, take her in for SURE. Especially if her eyes are yellowing. My eyes are not yellowing. Right now they are just giving me fetanyl patch, and diladid tramadol, baclofen, cymbalta, neurontin to calm my pain down to manageable. I dont know what they are going to do. i wasnt able to speak sentences my pain was so bad so they gave me all those meds. Ketamine infusions help alot with my burning, but I mean nothing helps EVERY symptom we have. if its not one thing its another. Thats how I feel. I havent tried hyperbarics. My friend Taylor did about 4 months of it, and saw no lasting difference, she just felt like she had more energy when she got out because of the increased oxygen. There is a dr 15 mins away that does hyper baric but, I dont know. I have tried EVERY natural thing, every chiro, massage, pt etc and they all just increase my pain alot. It might feel better for 5 minutes, but in the long run it makes me way worse. I feel for her, its hard in the eyes. let me know what you end up doing for her.

Hannah

Dear Sandy,

I'm really, really sorry that Lindsay is having such a hard time. Yellowing of the eyes could be a sign of jaundice - perhaps a blood test would be a good idea? I really hope you find an answer soon. Fentanyl worked really well for my pain when I needed it (although it was very hard to get off of!!).

Please take care, XOXOX Sandy

Quote:

Originally Posted by SandyS (Post 672265)

Not sure the remedy but..

Hi there, yes it certainly is possible to get CRPS in both the eyes and the ears, some signs to watch for with the eyes are swelling around the eyes and redness, unusual watering or dryness and watch for difrent dialation's in the pupils, your sympathetic system is responsible for pupil dialation and the parasympathetic system is responsible for pupil constriction.. This would also cause the person to have blurry eyes alot.
(I have a member of my site who submitted a close up picture of her eyes and I researched it further at the time.)

And ears ohh yes.. I have pictures of that on my research site as well, but I have only seen pictures of ears after a [head] injury the ears were all swollen just as any limb would get, but they swole closed pretty much, due in part I supose with having to lay on em all the time ect.

Here is a link to the sympathetic and parasympathetic functions:
http://www.facebook.com/photo.php?pi...d=172242468621

be well good luck,
~ Sandra

RSD/CRPS Research and Developements.
(my facebook research pages)

Thank you Sandra for the diagram. It was very helpful.

Sandy

Quote:

Originally Posted by Sandel (Post 672431)

Hi Sandy,

I am so sad right now, this is a whole new game plan. I looked up her meds and two can cause the yellowing and the eye pain. I am taking her in for a checkup tomorrow. She is due for blood work, but unfortunately the PM and the Pediatrician have to talk to see what they want to check out. But, I am putting my foot down tomorrow and demanding a script for the blood work immediately. This is so unfair to everyone with this horrib le disease. I hope that you are doing well, you seem to be.

Love Sandy

Quote:

Originally Posted by SandyRI (Post 672299)

"High dose" Ziconotide to the rescue?

Dear Hannah and Sandy -

Your circumstances are as difficult as I can imagine and clearly call for a certain "something else."

That something else may be Ziconotide, venom from a deadly South Pacific snail, which has gotten some attention in the last few years. I believe it's been a while since it's been mentioned and I think it bears repeating now. Please see my post (#12) of October 24, 2009, in the thread Radio Frequency Injections??? thread http://neurotalk.psychcentral.com/sh...d.php?p=582163:

Dear Sarah -

So very sorry you had such a miserable time yesterday.

I am, however, equally troubled by your doctor's suggestions that the only other techniques are "more invasive." This sounds 15 - 20 years out of date, where there exciting research is being done with medications.

If and when you have the energy, I would urge you to read "Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: A double-blind placebo controlled study," Schwartzman RJ, Alexander GM, Grothusen JR, Paylor T, Reichenberger E, Perreault M, Pain 2009 (in press), FREE FULL TEXT at http://www.rsds.org/2/library/articl...n_Pain2009.pdf

ABSTRACT
Complex regional pain syndrome (CRPS) is a severe chronic pain condition that most often develops following trauma. The pathophysiology of CRPS is not known but both clinical and experimental evidence demonstrate the important of the NMDA receptor and glial activation in its induction and maintenance. Ketamine is the most potent clinically available safe NMDA antagonist that has a well established role in the treatment of acute and chronic pain. This randomized double-blind placebo controlled trial was designed to evaluate the effectiveness of intravenous ketamine in the treatment of CRPS. Before treatment, after informed consent was obtained, each subject was randomized into a ketamine or a placebo infusion group. Study subjects were evaluated for at least 2 weeks prior to treatment and for 3 months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4 h (25 ml/h) daily for 10 days. The maximum ketamine infusion rate was 0.35 mg/kg/h, not to exceed 25 mg/h over a 4 h period. Subjects in both the ketamine and placebo groups were administered clonidine and versed. This study showed that intravenous ketamine administered in an outpatient setting resulted in statistically significant (p < 0.05) reductions in many pain parameters. It also showed that subjects in our placebo group demonstrated no treatment effect in any parameter. The results of this study warrant a larger randomized placebo controlled trial using higher doses of ketamine and a longer follow-up period.

(c) 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

What's so significant about these results, as you can see reading the study, the study, is that no effort was made to limit the study participants to individuals who had been symptomatic for six months or less at the time of treatment: a group that is far more likely to benefit from any number of therapies than are those [whose condition has become chronic].

And on a different but also promising tract, please read "An Effective Treatment of Severe Complex Regional Pain Syndrome Type 1 in a Child Using High Doses of Intrathecal Ziconotide (Letter to the Editor)," Stanton-Hicks MD, Kapural L, J Pain Symptom Management 2006;6:509-510, FREE FULL TEXT (and a couple of amazing photos) at http://www.rsds.org/2/library/articl...32_6_pg509.pdf, which was followed more recently by "Intrathecal ziconotide for complex regional pain syndrome: seven case reports," Kapural L, Lokey K, Leong MS, Fiekowsky S, Stanton-Hicks M, Sapienza-Crawford AJ, Webster LR, Pain Practioner 2009 Jul-Aug;9(4):296-303:

ABSTRACT
Ziconotide is a nonopioid analgesic currently indicated as monotherapy, but frequently used in combination with opioids, for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of, or whose pain is, refractory to other treatments. There is a paucity of information regarding ziconotide use in patients with complex regional pain syndrome (CRPS). Seven cases in which IT ziconotide was used in patients with CRPS were analyzed. All patients (4 male, 3 female; age range, 14 to 52 years) had experienced inadequate pain relief with multiple conventional and interventional treatments. Three patients received ziconotide monotherapy exclusively; 4 patients received ziconotide monotherapy initially, then combination IT therapy. The mean ziconotide dose was 5.2 mcg/d (range, 0.5 to 13 mcg/d) at initiation and 24.7 mcg/d (range, 0.06 to 146 mcg/d) at the last available assessment. The mean duration of ziconotide therapy was 3.1 years (range, 26 days to 8 years). At ziconotide initiation, the mean visual analog scale (VAS) score was 89.3 mm (range, 75 to 100 mm); VAS scores decreased by a mean of 47.5% (range, 5% to 100%) at last assessment. Of the 5 patients who experienced substantial improvement in pain, edema, skin abnormalities, and/or mobility with ziconotide therapy, 2 have discontinued ziconotide and are pain free. Another patient experienced marked reversal of both edema and advanced skin trophic changes. Adverse events included urinary retention, depression, anxiety, and hallucinations. Adverse events generally resolved spontaneously, with treatment, or with ziconotide discontinuation/dose reduction. Although further studies are required, ziconotide holds promise as an effective treatment for CRPS.

PMID: 19500276 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

And note that the reported success rates in the foregoing studies were considerably better than the 1:5 you were quoted [for radio frequency ablation].

I apologize for laying all this on you. I just want you to know that there are kinder/gentler options out therebefore you return to your local butcher: even if he's on the faculty of a very good medical school, he's living in the past. So what I am suggesting is that before seeking further treatments from the same fellow, you seek another opinion. Since you live in Illinois, I would suggest the Cleveland Clinic, and specifically Michael Stanton-Hicks, M.D. Where he is now on senior status, I have been told by his department that he only sees patients with established cases of CRPS and then will do so only after first reviewing their medical records. Here's his directory page at the Cleveland Clinic http://my.clevelandclinic.org/staff_...taff_1175.aspx I believe the number for reaching his secretary is (216) 444-7246.

Finally, here's his departmental homepage http://my.clevelandclinic.org/anesth...t/default.aspx.

And once again, I am so sorry for what you are going through . . . .

Since then, I have become aware of one article suggesting that there may be not only dose related effectiveness issues but dose-dependant safety issues as well. Considerations and methodology for trialing ziconotide, Burton AW, Deer TR, Wallace MS, Rauck RL, Grigsby E, Pain Physician 2010 Jan;13(1):23-33:

University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. awburton@mdanderson.org

Abstract
BACKGROUND: Before long-term intrathecal analgesic therapy is initiated, patients often undergo a spinal analgesia trial. Ziconotide is a nonopioid intrathecal analgesic used to manage severe chronic pain, and a variety of methods have been used to trial ziconotide. OBJECTIVES: The purpose of this review is to compare and discuss the different methods of ziconotide trialing. METHODS: Various databases (i.e., PubMed, Excerpta Medica, Cumulative Index to Nursing and Allied Health Literature, Biological Abstracts, Cochrane Database of Systematic Reviews, EMBASE, International Pharmaceutical Abstracts, and Google Scholar) and association meeting abstracts were searched with the use of the terms ziconotide, Prialt, trial, and trialing. In addition, a search was conducted for abstracts/posters presented at a variety of association meetings. RESULTS: Nine sources, including one expert opinion piece, were identified. Three methods of ziconotide trialing were discovered: continuous infusion, limited-duration infusion, and bolus injection. Results indicate that patients often achieve analgesia during trialing, regardless of the trialing method. Adverse events reported during ziconotide trialing studies were similar to those reported during ziconotide clinical trials. Preliminary evidence suggests that both effectiveness and safety may be dose-related. In 3 studies the value of ziconotide trialing in predicting long-term patient response to ziconotide therapy was investigated; however, the results were preliminary. The expert opinion piece from 2008 recommended trialing ziconotide via continuous infusion, using a starting dose of 1.2 mcg/d and dose increases of 1.2 mcg/d every 12 to 24 hours, for up to 3 days; the trial may be extended in some cases. LIMITATIONS: Given the small samples size and lack of controlled ziconotide trialing studies, it is currently not possible to determine the relative safety and effectiveness of different methods of ziconotide trialing, nor is it possible to determine if trialing is predictive of patient response to long-term ziconotide therapy. CONCLUSIONS: All 3 methods of ziconotide trialing appear to be viable options, and no method can be considered superior on the basis of the evidence presented in this review. Controlled studies comparing ziconotide trialing methods may be warranted.

PMID: 20119460 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/20119460 [While it purports to be a "free article," the only way you can get it freely is if you have never signed up with the publisher before; nor was I keen to buy it from the publisher on terms that I not share (even freely) with anyone else.]

That said, one of the authors in the most recent review article was the senior author in a published a study done a year earlier, to the effect that side effects were NOT dose dependent, so I don't know what to make of it. See, Long-term intrathecal ziconotide for chronic pain: an open-label study, Webster LR, Fisher R, Charapata S, Wallace MS, J Pain Symptom Manage. 2009 Mar;37(3):363-72. Epub 2008 Aug 19:

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.com

Abstract
This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated. [Emphasis added.]

PMID: 18715748 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/18715748

Someone cynical might wish to suggest that the manufacturers of implanted pumps might look unkindly on one-time in-patient treatments resulting in complete cures, but that's not for me to say.

In any event, I repeat my suggestion to contact Dr. Stanton-Hick's secretary for an appointment. [However, as set forth below, I am willing accept to the verdict that Dr. Stanton-Hick's doesn't buy off on occular RSD; but that does not deminish my interest in what he is doing with "high dose" Ziconotide for whatever else may ail us.]

Mike

Hi Mike,

Thank you so much for your post, also it is nice to put a face to your posts! :) My Lindsay has been to the Cleveland Clinic and saw Stanton-Hicks. He didn't feel she was a candidate. I do however know of a young girl that has had the "Snail Poison" She was in stage 3, they put it in at the Cleveland Clinic. It did help her, she was in a wheel chair and in stage three of her plight. She spent 3 months in the Childrens pain rehab program. She is now walking and functioning after three years. However, Lindsay was not a candidate.
Lindsay has also undergone two rounds of the three day four hour Ketamine infusions with Dr. Kirkpatrick. She is not up to doing the Ketamine again. But, I am going to try the Hyperbaric chamber. You always have such great information. How are you? I hope that your days are better.

:hug:Sandy

Quote:

Originally Posted by fmichael (Post 672511)

Dear Sarah -

So very sorry you had such a miserable time yesterday.

I am, however, equally troubled by your doctor's suggestions that the only other techniques are "more invasive." This sounds 15 - 20 years out of date, where there exciting research is being done with medications.

If and when you have the energy, I would urge you to read "Outpatient intravenous ketamine for the treatment of complex regional pain syndrome: A double-blind placebo controlled study," Schwartzman RJ, Alexander GM, Grothusen JR, Paylor T, Reichenberger E, Perreault M, Pain 2009 (in press), FREE FULL TEXT at http://www.rsds.org/2/library/articl...n_Pain2009.pdf

ABSTRACT
Complex regional pain syndrome (CRPS) is a severe chronic pain condition that most often develops following trauma. The pathophysiology of CRPS is not known but both clinical and experimental evidence demonstrate the important of the NMDA receptor and glial activation in its induction and maintenance. Ketamine is the most potent clinically available safe NMDA antagonist that has a well established role in the treatment of acute and chronic pain. This randomized double-blind placebo controlled trial was designed to evaluate the effectiveness of intravenous ketamine in the treatment of CRPS. Before treatment, after informed consent was obtained, each subject was randomized into a ketamine or a placebo infusion group. Study subjects were evaluated for at least 2 weeks prior to treatment and for 3 months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4 h (25 ml/h) daily for 10 days. The maximum ketamine infusion rate was 0.35 mg/kg/h, not to exceed 25 mg/h over a 4 h period. Subjects in both the ketamine and placebo groups were administered clonidine and versed. This study showed that intravenous ketamine administered in an outpatient setting resulted in statistically significant (p < 0.05) reductions in many pain parameters. It also showed that subjects in our placebo group demonstrated no treatment effect in any parameter. The results of this study warrant a larger randomized placebo controlled trial using higher doses of ketamine and a longer follow-up period.

(c) 2009 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

What's so significant about these results, as you can see reading the study, the study, is that no effort was made to limit the study participants to individuals who had been symptomatic for six months or less at the time of treatment: a group that is far more likely to benefit from any number of therapies than are those [whose condition has become chronic].

And on a different but also promising tract, please read "An Effective Treatment of Severe Complex Regional Pain Syndrome Type 1 in a Child Using High Doses of Intrathecal Ziconotide (Letter to the Editor)," Stanton-Hicks MD, Kapural L, J Pain Symptom Management 2006;6:509-510, FREE FULL TEXT (and a couple of amazing photos) at http://www.rsds.org/2/library/articl...32_6_pg509.pdf, which was followed more recently by "Intrathecal ziconotide for complex regional pain syndrome: seven case reports," Kapural L, Lokey K, Leong MS, Fiekowsky S, Stanton-Hicks M, Sapienza-Crawford AJ, Webster LR, Pain Practioner 2009 Jul-Aug;9(4):296-303:

ABSTRACT
Ziconotide is a nonopioid analgesic currently indicated as monotherapy, but frequently used in combination with opioids, for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of, or whose pain is, refractory to other treatments. There is a paucity of information regarding ziconotide use in patients with complex regional pain syndrome (CRPS). Seven cases in which IT ziconotide was used in patients with CRPS were analyzed. All patients (4 male, 3 female; age range, 14 to 52 years) had experienced inadequate pain relief with multiple conventional and interventional treatments. Three patients received ziconotide monotherapy exclusively; 4 patients received ziconotide monotherapy initially, then combination IT therapy. The mean ziconotide dose was 5.2 mcg/d (range, 0.5 to 13 mcg/d) at initiation and 24.7 mcg/d (range, 0.06 to 146 mcg/d) at the last available assessment. The mean duration of ziconotide therapy was 3.1 years (range, 26 days to 8 years). At ziconotide initiation, the mean visual analog scale (VAS) score was 89.3 mm (range, 75 to 100 mm); VAS scores decreased by a mean of 47.5% (range, 5% to 100%) at last assessment. Of the 5 patients who experienced substantial improvement in pain, edema, skin abnormalities, and/or mobility with ziconotide therapy, 2 have discontinued ziconotide and are pain free. Another patient experienced marked reversal of both edema and advanced skin trophic changes. Adverse events included urinary retention, depression, anxiety, and hallucinations. Adverse events generally resolved spontaneously, with treatment, or with ziconotide discontinuation/dose reduction. Although further studies are required, ziconotide holds promise as an effective treatment for CRPS.

PMID: 19500276 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

And note that the reported success rates in the foregoing studies were considerably better than the 1:5 you were quoted [for radio frequency ablation].

I apologize for laying all this on you. I just want you to know that there are kinder/gentler options out therebefore you return to your local butcher: even if he's on the faculty of a very good medical school, he's living in the past. So what I am suggesting is that before seeking further treatments from the same fellow, you seek another opinion. Since you live in Illinois, I would suggest the Cleveland Clinic, and specifically Michael Stanton-Hicks, M.D. Where he is now on senior status, I have been told by his department that he only sees patients with established cases of CRPS and then will do so only after first reviewing their medical records. Here's his directory page at the Cleveland Clinic http://my.clevelandclinic.org/staff_...taff_1175.aspx I believe the number for reaching his secretary is (216) 444-7246.

Finally, here's his departmental homepage http://my.clevelandclinic.org/anesth...t/default.aspx.

And once again, I am so sorry for what you are going through . . . .

University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. awburton@mdanderson.org

Abstract
BACKGROUND: Before long-term intrathecal analgesic therapy is initiated, patients often undergo a spinal analgesia trial. Ziconotide is a nonopioid intrathecal analgesic used to manage severe chronic pain, and a variety of methods have been used to trial ziconotide. OBJECTIVES: The purpose of this review is to compare and discuss the different methods of ziconotide trialing. METHODS: Various databases (i.e., PubMed, Excerpta Medica, Cumulative Index to Nursing and Allied Health Literature, Biological Abstracts, Cochrane Database of Systematic Reviews, EMBASE, International Pharmaceutical Abstracts, and Google Scholar) and association meeting abstracts were searched with the use of the terms ziconotide, Prialt, trial, and trialing. In addition, a search was conducted for abstracts/posters presented at a variety of association meetings. RESULTS: Nine sources, including one expert opinion piece, were identified. Three methods of ziconotide trialing were discovered: continuous infusion, limited-duration infusion, and bolus injection. Results indicate that patients often achieve analgesia during trialing, regardless of the trialing method. Adverse events reported during ziconotide trialing studies were similar to those reported during ziconotide clinical trials. Preliminary evidence suggests that both effectiveness and safety may be dose-related. In 3 studies the value of ziconotide trialing in predicting long-term patient response to ziconotide therapy was investigated; however, the results were preliminary. The expert opinion piece from 2008 recommended trialing ziconotide via continuous infusion, using a starting dose of 1.2 mcg/d and dose increases of 1.2 mcg/d every 12 to 24 hours, for up to 3 days; the trial may be extended in some cases. LIMITATIONS: Given the small samples size and lack of controlled ziconotide trialing studies, it is currently not possible to determine the relative safety and effectiveness of different methods of ziconotide trialing, nor is it possible to determine if trialing is predictive of patient response to long-term ziconotide therapy. CONCLUSIONS: All 3 methods of ziconotide trialing appear to be viable options, and no method can be considered superior on the basis of the evidence presented in this review. Controlled studies comparing ziconotide trialing methods may be warranted.

PMID: 20119460 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/20119460 [While it purports to be a "free article," the only way you can get it freely is if you have never signed up with the publisher before; nor was I keen to buy it from the publisher on terms that I not share (even freely) with anyone else.]

That said, one of the authors in the most recent paper was the senior author in a study published a study a year earlier, to the effect that side effects were not dose dependent, so I don't know what to make of it. See, Long-term intrathecal ziconotide for chronic pain: an open-label study, Webster LR, Fisher R, Charapata S, Wallace MS, J Pain Symptom Manage. 2009 Mar;37(3):363-72. Epub 2008 Aug 19:

Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.com

Abstract
This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated.

PMID: 18715748 [PubMed - indexed for MEDLINE]