Ketamine, the article

fmichael · 10-06-2009, 03:11 AM

Upon request, in the interest of wider circulation, I am putting up as a new thread, slightly modified version of a posting I put up a day or two ago in the ketamine infusions? thread. This is one article that merits all of our attention.

On September 22, 2009, PAIN, the most important journal in the field, anywhere in the world, electronically published a forthcoming article: 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 Sep 22. [Epub ahead of print] a full free text copy of which is now available on the RSDSA Medical Article Achieve page at http://www.rsds.org/2/library/articl...n_Pain2009.pdf The abstract follows:

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 3months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4h (25ml/h) daily for 10days. The maximum ketamine infusion rate was 0.35mg/kg/h, not to exceed 25mg/h over a 4h 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.

PMID: 19783371 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

While it's a small study, finishing up with only 19 participants, its importance cannot be overstated. First, by giving Clonidine and Versed (Midazolam) to all participants, whether they were receiving ketamine or in the control group, were, in the words of the conclusion, "positive placebos" that effected "blinding" on the part of all participants. This it becomes, unbelievably, the first double blinded placebo controlled study of intravenous ketamine in the treatment of CRPS. Granted, one of acknowledged the limitations of the study was its small size, but the robust nature of the results may be enough to secure NIH grants for larger studies. Studies from which WC carriers will hopefully find no escape.

Most surprisingly, the results of the study were obtained from a population of CRPS patients who had been ill for at least six months, and some much longer:

There were no significant differences between those patients with a shorter duration of CRPS (11 patients with an average length of illness of 2.6 years and a range of 0.8–4.2 years) and longstanding patients (8 patients with an average length of illness of 12.2 years and a range of 6.8–20 years).

Although perhaps at the behest of the reviewers, this result is qualified in the conclusion, it should be noted how this is seemingly at variance with a small study undertaken by his German colleagues on which Dr. Schwartzman was listed as the senior author, and in particular the lengthy discussion section at the end of the article. Kiefer RT, Rohr P, Ploppa A, et al, A Pilot Open-Label Study of the Efficacy of Subanesthetic Isometric S(+)-Ketamine in Refractory CRPS Patients, Pain Med. 2008;9(1):44-54 (among 4 female patients with mean duration of CRPS of 58 ± 20 months, subanesthetic S(+)- ketamine showed no reduction of pain and effected no change in thermo- and mechanical detection or pain thresholds), full text at http://www.rsds.org/2/library/articl...ohr_Ploppa.pdf

My only disappointment in the new article is that the study design carried over an exclusion criteria for glaucoma from the coma treatments, which made sense in that context where one's eyes apparently "bug out" during the coma, and the doctors feel that they have no means for controlling eye pressures during that time, but it's hard to see how the same rationale applies to sub-anesthetic out-patient infusions. (An issue that caught my attention where I had already purchased - on the last day anything other than full-fare coach prices were available - non-refundable tickets to Germany, before being definitively advised that the exclusion applied even to well controlled "open angle" glaucoma.) But that's just my vantage point. As set forth in the article, there are some other contraindications as well.

The new article is wonderful and the study design is tight. It looks as though all of Dr. Schwartzman's years of toil in the ketamine vineyards may be on the verge of bearing fruit in the manner in which CRPS patients can be treated across North America.

Mike

SandyS · 10-06-2009, 04:21 PM

Mike, You Rock!

Quote:

Originally Posted by fmichael

Upon request, in the interest of wider sirculation, I am putting up as a new thread, slightly modified version of a posting I put up a day or two ago in the ketamine infusions? thread. This is one article that merits all of our attention.

On September 22, 2009, PAIN, the most important journal in the field, anywhere in the world, electronically published a forthcoming article: 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 Sep 22. [Epub ahead of print] a full free text copy of which is now available on the RSDSA Medical Article Achieve page at http://www.rsds.org/2/library/articl...n_Pain2009.pdf The abstract follows:

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 3months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4h (25ml/h) daily for 10days. The maximum ketamine infusion rate was 0.35mg/kg/h, not to exceed 25mg/h over a 4h 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.

PMID: 19783371 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

While it's a small study, finishing up with only 19 participants, its importance cannot be overstated. First, by giving Clonidine and Versed (Midazolam) to all participants, whether they were receiving ketamine or in the control group, were, in the words of the conclusion, "positive placebos" that effected "blinding" on the part of all participants. This it becomes, unbelievably, the first double blinded placebo controlled study of intravenous ketamine in the treatment of CRPS. Granted, one of acknowledged the limitations of the study was its small size, but the robust nature of the results may be enough to secure NIH grants for larger studies. Studies from which WC carriers will hopefully find no escape.

Most surprisingly, the results of the study were obtained from a population of CRPS patients who had been ill for at least six months, and some much longer:

There were no significant differences between those patients with a shorter duration of CRPS (11 patients with an average length of illness of 2.6 years and a range of 0.8–4.2 years) and longstanding patients (8 patients with an average length of illness of 12.2 years and a range of 6.8–20 years).

Although perhaps at the behest of the reviewers, this result is qualified in the conclusion, it should be noted how this is seemingly at variance with a small study undertaken by his German colleagues on which Dr. Schwartzman was listed as the senior author, and in particular the lengthy discussion section at the end of the article. Kiefer RT, Rohr P, Ploppa A, et al, A Pilot Open-Label Study of the Efficacy of Subanesthetic Isometric S(+)-Ketamine in Refractory CRPS Patients, Pain Med. 2008;9(1):44-54 (among 4 female patients with mean duration of CRPS of 58 ± 20 months, subanesthetic S(+)- ketamine showed no reduction of pain and effected no change in thermo- and mechanical detection or pain thresholds), full text at http://www.rsds.org/2/library/articl...ohr_Ploppa.pdf

My only disappointment in the new article is that the study design carried over an exclusion criteria for glaucoma from the coma treatments, which made sense in that context where one's eyes apparently "bug out" during the coma, and the doctors feel that they have no means for controlling eye pressures during that time, but it's hard to see how the same rationale applies to sub-anesthetic out-patient infusions. (An issue that caught my attention where I had already purchased - on the last day anything other than full-fare coach prices were available - non-refundable tickets to Germany, before being definitively advised that the exclusion applied even to well controlled "open angle" glaucoma.) But that's just my vantage point. As set forth in the article, there are some other contraindications as well.

The new article is wonderful and the study design is tight. It looks as though all of Dr. Schwartzman's years of toil in the ketamine vineyards may be on the verge of bearing fruit in the manner in which CRPS patients can be treated across North America.

Mike

cindi1965 · 10-07-2009, 09:35 PM

I just pray that I never have to make the choice with Ketamine. It scares me to death as I used to work with severe behavior autistic people at a residential facility in the late 80's and they gave them Ketamine for surgeries and I was always picked to sit with them, because I was young and had the patience to do so. It was so horrible watching the effects of the drugs on them waking up. One time I had to stay with a resident for 3 days because she had a extreme reaction to the drug and her parents lived so far away and didn't have the means to get to her.

Now, I am quite sure that things have changed since the 80's,but seeing that poor young lady go through what she did will haunt me forever.

Thanks for posting the article

fmichael · 10-07-2009, 10:13 PM

Quote:

Originally Posted by cindi1965

I just pray that I never have to make the choice with Ketamine. It scares me to death as I used to work with severe behavior autistic people at a residential facility in the late 80's and they gave them Ketamine for surgeries and I was always picked to sit with them, because I was young and had the patience to do so. It was so horrible watching the effects of the drugs on them waking up. One time I had to stay with a resident for 3 days because she had a extreme reaction to the drug and her parents lived so far away and didn't have the means to get to her.

Now, I am quite sure that things have changed since the 80's,but seeing that poor young lady go through what she did will haunt me forever.

Thanks for posting the article

Hi Cindi -

Thank you for that, there's nothing like making it real. While you note that you're sure things have changed since the 80's, would you by any chance have known then (or do do know now) what drugs, if any, were given to soften the impact of ketamine, as Clonidine and Versed are prescribed today? Consider it a request for an elaboration of that vivid if brief image you have shared from a not so distant past in medicine: which clearly visited abuse upon you as well as those in your charge.

Also, were these autistic "residents" having surgeries at a higher rate than, say, people of the same age in the general population, and if so, why? Thanks.

Mike

gabbycakes · 10-08-2009, 07:36 AM

Mike,

First, let me say thank you for the time and effort you put in to your post. They are extremely detailed and very informative and I truly appreciate it.

I have had 3 - 5 day inpatient ketamine infusions with boosters. I worked with doctors in NYC and Dr. Schrwartzman. I had good results. Without getting into a book of explanation the ketamine treatments settled all of the symptoms on the scale I would say I was at an 9 when I started and today I would say I go up and down from a 2 to a 5 based on the weather and other factors.

My question to you is have you ever come across any studies of the effects, long term from the ketamine. I have had some strange things happen, nothing really serious, but just change. Example I always had good healthy teeth, now I am at the dentist for some reason or another for i.e cavities, root canals, extractions etc, every 3 months. My dentist thinks the ketamine damaged the PH in my system in turn effected my teeth.

If you have any direction you can point me in to find out more on this subject I would appreciate this.

I know Parke-Davis makes ketamine so I am trying to contact them to get some solid information. Or at least I think it's Parke-Davis.

Thank you,

Gabbycakes

Quote:

Originally Posted by fmichael

Hi Cindi -

Thank you for that, there's nothing like making it real. While you note that you're sure things have changed since the 80's, would you by any chance have known then (or do do know now) what drugs, if any, were given to soften the impact of ketamine, as Clonidine and Versed are prescribed today? Consider it a request for an elaboration of that vivid if brief image you have shared from a not so distant past in medicine: which clearly visited abuse upon you as well as those in your charge.

Also, were these autistic "residents" having surgeries at a higher rate than, say, people of the same age in the general population, and if so, why? Thanks.

Mike

cindi1965 · 10-10-2009, 06:40 PM

Quote:

Originally Posted by fmichael

Hi Cindi -

Thank you for that, there's nothing like making it real. While you note that you're sure things have changed since the 80's, would you by any chance have known then (or do do know now) what drugs, if any, were given to soften the impact of ketamine, as Clonidine and Versed are prescribed today? Consider it a request for an elaboration of that vivid if brief image you have shared from a not so distant past in medicine: which clearly visited abuse upon you as well as those in your charge.

Also, were these autistic "residents" having surgeries at a higher rate than, say, people of the same age in the general population, and if so, why? Thanks.

Mike

Mike,
I don't know if there were any other drugs given to the patients, all I know is that they were tethered to the bed or chair after surgery and they were so very sick for days afterward. I was just doing my job and driving them to their appts In the 80's I'm not so sure that doctors had the compassion or sense to realize that they were human beings. I would have to see a Ketamine infusion in person before I would believe in it. That's me and my personal experience.

fmichael · 10-11-2009, 06:08 PM

Quote:

Originally Posted by gabbycakes

Mike,

First, let me say thank you for the time and effort you put in to your post. They are extremely detailed and very informative and I truly appreciate it.

I have had 3 - 5 day inpatient ketamine infusions with boosters. I worked with doctors in NYC and Dr. Schrwartzman. I had good results. Without getting into a book of explanation the ketamine treatments settled all of the symptoms on the scale I would say I was at an 9 when I started and today I would say I go up and down from a 2 to a 5 based on the weather and other factors.

My question to you is have you ever come across any studies of the effects, long term from the ketamine. I have had some strange things happen, nothing really serious, but just change. Example I always had good healthy teeth, now I am at the dentist for some reason or another for i.e cavities, root canals, extractions etc, every 3 months. My dentist thinks the ketamine damaged the PH in my system in turn effected my teeth.

If you have any direction you can point me in to find out more on this subject I would appreciate this.

I know Parke-Davis makes ketamine so I am trying to contact them to get some solid information. Or at least I think it's Parke-Davis.

Thank you,

Gabbycakes

Dear Gabbycakes -

My apologies for the delay in getting back to you, however, I haven't been able to find much. Ketamine is, as you are aware is formulated as "a slightly acid (pH 3.5-5.5)." See, Prescribing Information for Ketalar® (Ketamine Hydrochloride Injection, USP), in pdf format: http://www.jhppharma.com/products/PI...ar-Full-PI.pdf

In fact, there is one recent report in which it has been used in combination with propofol to lower the pH of strait 1% propofol injection from 7.86 to 5.84 when administered as a 1% propofol-ketamine, thereby reducing the painfulness of the injection itself. Preventing pain on injection of propofol: a comparison between peripheral ketamine pre-treatment and ketamine added to propofol. Hwang J, Park HP, Lim YJ, Do SH, Lee SC, Jeon YT, Anaesth. Intensive Care 2009 Jul; 37(4): 584-7:

Abstract
The purpose of this study was to examine possible peripheral mechanisms for the reduction of propofol injection pain by the addition of ketamine. We hypothesised that pH changes associated with the addition of ketamine to propofol decrease propofol-induced pain on injection. We compared the efficacy of intravenous ketamine pretreatment under tourniquet with ketamine added to the propofol. In the pre-treatment group, patients received ketamine 10 mg in a total volume of 1.0 ml with 0.9% saline (n = 94; Group P) under tourniquet for 30 seconds before administration of propofol after release of the tourniquet. In the mixture group, propofol 9 ml was mixed with ketamine 10 mg in 0.9% NaCl 1.0 ml (n = 94, Group M). Pain was assessed with a four-point scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain at the time of propofol injection. The pH of propofol, ketamine and a range of propofol-ketamine mixtures were also measured. Forty-eight patients (51%) in Group P complained of pain on injection compared with 28 patients (30%) in Group M (P = 0.005). The pH of the 1% propofol-ketamine mixture was 5.84 while 1% propofol had a pH of 7.86. Our results support pH changes as a more important cause for the decrease in propofol injection pain with the addition of ketamine to propofol than a peripheral effect of ketamine.

PMID: 19681415 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

That said, how quickly the body responds to changes in pH and the mechanisms by which it does so are matters well beyond my understanding: something one would have to know before establishing a link between the infusion of ketamine and tooth damage. Sorry I can't be more helpful.

Mike

gabbycakes · 10-12-2009, 02:55 PM

Thanks for the info. Mike

Gabbycakes...

Quote:

Originally Posted by fmichael

Dear Gabbycakes -

My apologies for the delay in getting back to you, however, I haven't been able to find much. Ketamine is, as you are aware is formulated as "a slightly acid (pH 3.5-5.5)." See, Prescribing Information for Ketalar® (Ketamine Hydrochloride Injection, USP), in pdf format: http://www.jhppharma.com/products/PI...ar-Full-PI.pdf

In fact, there is one recent report in which it has been used in combination with propofol to lower the pH of strait 1% propofol injection from 7.86 to 5.84 when administered as a 1% propofol-ketamine, thereby reducing the painfulness of the injection itself. Preventing pain on injection of propofol: a comparison between peripheral ketamine pre-treatment and ketamine added to propofol. Hwang J, Park HP, Lim YJ, Do SH, Lee SC, Jeon YT, Anaesth. Intensive Care 2009 Jul; 37(4): 584-7:

Abstract
The purpose of this study was to examine possible peripheral mechanisms for the reduction of propofol injection pain by the addition of ketamine. We hypothesised that pH changes associated with the addition of ketamine to propofol decrease propofol-induced pain on injection. We compared the efficacy of intravenous ketamine pretreatment under tourniquet with ketamine added to the propofol. In the pre-treatment group, patients received ketamine 10 mg in a total volume of 1.0 ml with 0.9% saline (n = 94; Group P) under tourniquet for 30 seconds before administration of propofol after release of the tourniquet. In the mixture group, propofol 9 ml was mixed with ketamine 10 mg in 0.9% NaCl 1.0 ml (n = 94, Group M). Pain was assessed with a four-point scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain at the time of propofol injection. The pH of propofol, ketamine and a range of propofol-ketamine mixtures were also measured. Forty-eight patients (51%) in Group P complained of pain on injection compared with 28 patients (30%) in Group M (P = 0.005). The pH of the 1% propofol-ketamine mixture was 5.84 while 1% propofol had a pH of 7.86. Our results support pH changes as a more important cause for the decrease in propofol injection pain with the addition of ketamine to propofol than a peripheral effect of ketamine.

PMID: 19681415 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

That said, how quickly the body responds to changes in pH and the mechanisms by which it does so are matters well beyond my understanding: something one would have to know before establishing a link between the infusion of ketamine and tooth damage. Sorry I can't be more helpful.

Mike

CZZ74 · 10-15-2009, 05:00 PM

Quote:

Originally Posted by fmichael

Upon request, in the interest of wider circulation, I am putting up as a new thread, slightly modified version of a posting I put up a day or two ago in the ketamine infusions? thread. This is one article that merits all of our attention.

On September 22, 2009, PAIN, the most important journal in the field, anywhere in the world, electronically published a forthcoming article: 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 Sep 22. [Epub ahead of print] a full free text copy of which is now available on the RSDSA Medical Article Achieve page at http://www.rsds.org/2/library/articl...n_Pain2009.pdf The abstract follows:

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 3months following treatment. All subjects were infused intravenously with normal saline with or without ketamine for 4h (25ml/h) daily for 10days. The maximum ketamine infusion rate was 0.35mg/kg/h, not to exceed 25mg/h over a 4h 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.

PMID: 19783371 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

While it's a small study, finishing up with only 19 participants, its importance cannot be overstated. First, by giving Clonidine and Versed (Midazolam) to all participants, whether they were receiving ketamine or in the control group, were, in the words of the conclusion, "positive placebos" that effected "blinding" on the part of all participants. This it becomes, unbelievably, the first double blinded placebo controlled study of intravenous ketamine in the treatment of CRPS. Granted, one of acknowledged the limitations of the study was its small size, but the robust nature of the results may be enough to secure NIH grants for larger studies. Studies from which WC carriers will hopefully find no escape.

Most surprisingly, the results of the study were obtained from a population of CRPS patients who had been ill for at least six months, and some much longer:

There were no significant differences between those patients with a shorter duration of CRPS (11 patients with an average length of illness of 2.6 years and a range of 0.8–4.2 years) and longstanding patients (8 patients with an average length of illness of 12.2 years and a range of 6.8–20 years).

Although perhaps at the behest of the reviewers, this result is qualified in the conclusion, it should be noted how this is seemingly at variance with a small study undertaken by his German colleagues on which Dr. Schwartzman was listed as the senior author, and in particular the lengthy discussion section at the end of the article. Kiefer RT, Rohr P, Ploppa A, et al, A Pilot Open-Label Study of the Efficacy of Subanesthetic Isometric S(+)-Ketamine in Refractory CRPS Patients, Pain Med. 2008;9(1):44-54 (among 4 female patients with mean duration of CRPS of 58 ± 20 months, subanesthetic S(+)- ketamine showed no reduction of pain and effected no change in thermo- and mechanical detection or pain thresholds), full text at http://www.rsds.org/2/library/articl...ohr_Ploppa.pdf

My only disappointment in the new article is that the study design carried over an exclusion criteria for glaucoma from the coma treatments, which made sense in that context where one's eyes apparently "bug out" during the coma, and the doctors feel that they have no means for controlling eye pressures during that time, but it's hard to see how the same rationale applies to sub-anesthetic out-patient infusions. (An issue that caught my attention where I had already purchased - on the last day anything other than full-fare coach prices were available - non-refundable tickets to Germany, before being definitively advised that the exclusion applied even to well controlled "open angle" glaucoma.) But that's just my vantage point. As set forth in the article, there are some other contraindications as well.

The new article is wonderful and the study design is tight. It looks as though all of Dr. Schwartzman's years of toil in the ketamine vineyards may be on the verge of bearing fruit in the manner in which CRPS patients can be treated across North America.

Mike

Mike thanks for this, If I amnot a patient in this I would be shocked! lol Anyway I have anxiously been awaiting this article. thank you for making it available Mike . It is so so important. cz

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