IM Ketorolac Versus OMT: Was Agent at Peak Analgesic Effect in JAOA Study
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《美国整骨期刊》
American Board of Anesthesiology
Department of Anesthesiology Park Ridge Hospital – Surgical Services Fletcher, North Carolina
Tamara M. McReynolds, DO, and Barry J. Sheridan, DO, have written a thoughtful article titled "Intramuscular Ketorolac Versus Osteopathic Manipulative Treatment in the Management of Acute Neck Pain the Emergency Department: A Randomized Clinical Trial" (2005; 105:57–68). I have one concern about their conclusion, however, that osteopathic manipulative treatment (OMT) is as efficacious as ketorolac tromethamine injected intramuscularly (IM) when treating this patient population.
The authors have set the study's endpoint at one hour after treatment. However, official product information from Roche Pharmaceuticals, as noted in the 2005 edition of Physicians' Desk Reference,1 indicates that maximum efficacy of IM ketorolac is reached at two to three hours after administration.
McReynolds and Sheridan conclude that IM ketorolac, 30 mg, and OMT are equally efficacious at one hour posttreatment.
My question for the authors is as follows: Is OMT equally efficacious with IM ketorolac, 30 mg, when the agent is at its peak analgesic effect, that is at 2 to 3 hours after administration To me, this is the more important question.
I would suggest that comparison of the two treatment modalities at one, two, and four hours posttreatment would have made a good study even better.
References
1. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Clinical Pharmacology. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2933 .
Response
Tamara M. McReynolds, DO
Barry J. Sheridan, DO
Dr Coston raises an excellent question regarding the time to peak analgesic effect for ketorolac tromethamine injected intramuscularly (IM). The Physicians' Desk Reference (PDR) presents some inconsistencies with regard to the time required for the analgesic to reach peak effect in patients.
In the Clinical Pharmacology section under Pharmacodynamics, the PDR states, "The peak analgesic effect of TORODOL occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of TORODOL."1
In contrast, the Dosage and Administration section states, "The analgesic effect begins in 30 minutes with maximum effect in 1 to 2 hours after dosing [intravenously] or IM...."2
In addition, as provided in Table 1 of the PDR listing, which provides approximate average pharmacokinetic parameters for Toradol, the Tmax (time-to-peak plasma concentration) is 44 ± 29 minutes.
We contacted Roche (Nutley, NJ) in March 2005 for clarification, and a spokesperson from Roche Professional Product Information (oral communication, data on file) provided the following information:
In the Clinical Pharmacology section under Pharmacodynamics, peak analgesic effect1 refers to "the highest plasma level that occurs within 2 to 3 hours."
In the Dosage and Administration section, with maximum effect in 1 to 2 hours2 refers to the "maximum (best) analgesic effect of Toradol, which may occur anywhere from 1 to 2 hours."
The time to peak plasma concentration is the "time of onset to peak plasma level, which occurs within 44 ± 29 minutes."
In our February 2005 study ("Intramuscular Ketorolac Versus Osteopathic Manipulative Treatment in the Management of Acute Neck Pain the Emergency Department: A Randomized Clinical Trial."2005;105:57–68), we focused on the rapid relief of neck pain in the emergency department. We elected to observe the effects of single-dose IM ketorolac at a maximum observation time of 1 hour as other investigators have also done.3–9
We acknowledge that results may have differed if observation times had been extended to one, two, and four hours posttreatment as suggested by Dr Coston.
Darnall Army Community Hospital
Fort Hood, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas
References
1. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Clinical Pharmacology. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2933 .
2. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Dosage and Administration. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2936 .
3. Bartfield JM, Kern AM, Raccio-Robak N, Snyder HS, Baevsky RH. Ketorolac tromethamine use in a university-based emergency department. Acad Emerg Med.1994; 1:532 –538.
4. Veenema KR, Leahey N, Schneider S. Ketorolac versus meperidine: ED treatment of severe musculoskeletal low back pain. Am J Emerg Med. 2000;18:404 –407.
5. Davis CP, Torre PR, Schafer NC, Dave B, Bass B Jr. Ketorolac as a rapid and effective treatment of migraine headache: evaluations by patients. Am J Emerg Med.1993; 11:573 –575.
6. Duarte C, Dunaway F, Turner L, Aldag J, Frederick R. Ketorolac versus meperidine and hydroxyzine in the treatment of acute migraine headache: a randomized, prospective, double-blind trial. Ann Emerg Med. 1992;21:1116 –1121.
7. Harden RN, Gracely RH, Carter T, Warner G. The placebo effect in acute headache management: ketorolac, meperidine, and saline in the emergency department. Headache.1996; 36:352 –356.
8. Klapper JA, Stanton JS. Ketorolac versus DHE and metoclopramide in the treatment of migraine headaches. Headache.1991; 31:523 –524.
9. Larkin GL, Prescott JE. A randomized, double-blind, comparative study of the efficacy of ketorolac tromethamine versus meperidine in the treatment of severe migraine. Ann Emerg Med.1992; 21:919 –924.(Jeffrey L. Coston, DO, Di)
Department of Anesthesiology Park Ridge Hospital – Surgical Services Fletcher, North Carolina
Tamara M. McReynolds, DO, and Barry J. Sheridan, DO, have written a thoughtful article titled "Intramuscular Ketorolac Versus Osteopathic Manipulative Treatment in the Management of Acute Neck Pain the Emergency Department: A Randomized Clinical Trial" (2005; 105:57–68). I have one concern about their conclusion, however, that osteopathic manipulative treatment (OMT) is as efficacious as ketorolac tromethamine injected intramuscularly (IM) when treating this patient population.
The authors have set the study's endpoint at one hour after treatment. However, official product information from Roche Pharmaceuticals, as noted in the 2005 edition of Physicians' Desk Reference,1 indicates that maximum efficacy of IM ketorolac is reached at two to three hours after administration.
McReynolds and Sheridan conclude that IM ketorolac, 30 mg, and OMT are equally efficacious at one hour posttreatment.
My question for the authors is as follows: Is OMT equally efficacious with IM ketorolac, 30 mg, when the agent is at its peak analgesic effect, that is at 2 to 3 hours after administration To me, this is the more important question.
I would suggest that comparison of the two treatment modalities at one, two, and four hours posttreatment would have made a good study even better.
References
1. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Clinical Pharmacology. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2933 .
Response
Tamara M. McReynolds, DO
Barry J. Sheridan, DO
Dr Coston raises an excellent question regarding the time to peak analgesic effect for ketorolac tromethamine injected intramuscularly (IM). The Physicians' Desk Reference (PDR) presents some inconsistencies with regard to the time required for the analgesic to reach peak effect in patients.
In the Clinical Pharmacology section under Pharmacodynamics, the PDR states, "The peak analgesic effect of TORODOL occurs within 2 to 3 hours and is not statistically significantly different over the recommended dosage range of TORODOL."1
In contrast, the Dosage and Administration section states, "The analgesic effect begins in 30 minutes with maximum effect in 1 to 2 hours after dosing [intravenously] or IM...."2
In addition, as provided in Table 1 of the PDR listing, which provides approximate average pharmacokinetic parameters for Toradol, the Tmax (time-to-peak plasma concentration) is 44 ± 29 minutes.
We contacted Roche (Nutley, NJ) in March 2005 for clarification, and a spokesperson from Roche Professional Product Information (oral communication, data on file) provided the following information:
In the Clinical Pharmacology section under Pharmacodynamics, peak analgesic effect1 refers to "the highest plasma level that occurs within 2 to 3 hours."
In the Dosage and Administration section, with maximum effect in 1 to 2 hours2 refers to the "maximum (best) analgesic effect of Toradol, which may occur anywhere from 1 to 2 hours."
The time to peak plasma concentration is the "time of onset to peak plasma level, which occurs within 44 ± 29 minutes."
In our February 2005 study ("Intramuscular Ketorolac Versus Osteopathic Manipulative Treatment in the Management of Acute Neck Pain the Emergency Department: A Randomized Clinical Trial."2005;105:57–68), we focused on the rapid relief of neck pain in the emergency department. We elected to observe the effects of single-dose IM ketorolac at a maximum observation time of 1 hour as other investigators have also done.3–9
We acknowledge that results may have differed if observation times had been extended to one, two, and four hours posttreatment as suggested by Dr Coston.
Darnall Army Community Hospital
Fort Hood, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas
References
1. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Clinical Pharmacology. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2933 .
2. Chesanow N, Fleming H, eds. TORADOL (ketorolac tromethamine injection). Dosage and Administration. Physicians' Desk Reference. 2005. 59th ed. Montvale, NJ: Thompson PDR; 2005:2936 .
3. Bartfield JM, Kern AM, Raccio-Robak N, Snyder HS, Baevsky RH. Ketorolac tromethamine use in a university-based emergency department. Acad Emerg Med.1994; 1:532 –538.
4. Veenema KR, Leahey N, Schneider S. Ketorolac versus meperidine: ED treatment of severe musculoskeletal low back pain. Am J Emerg Med. 2000;18:404 –407.
5. Davis CP, Torre PR, Schafer NC, Dave B, Bass B Jr. Ketorolac as a rapid and effective treatment of migraine headache: evaluations by patients. Am J Emerg Med.1993; 11:573 –575.
6. Duarte C, Dunaway F, Turner L, Aldag J, Frederick R. Ketorolac versus meperidine and hydroxyzine in the treatment of acute migraine headache: a randomized, prospective, double-blind trial. Ann Emerg Med. 1992;21:1116 –1121.
7. Harden RN, Gracely RH, Carter T, Warner G. The placebo effect in acute headache management: ketorolac, meperidine, and saline in the emergency department. Headache.1996; 36:352 –356.
8. Klapper JA, Stanton JS. Ketorolac versus DHE and metoclopramide in the treatment of migraine headaches. Headache.1991; 31:523 –524.
9. Larkin GL, Prescott JE. A randomized, double-blind, comparative study of the efficacy of ketorolac tromethamine versus meperidine in the treatment of severe migraine. Ann Emerg Med.1992; 21:919 –924.(Jeffrey L. Coston, DO, Di)