Compositions and methods for treatment of pediatric pain

Abstract

Disclosed are methods of treating pain in a mammal, which may include the step of administering human growth hormone to a mammal in need thereof. The pain treated by the disclosed methods may be of a type caused by inflammation induced mechanical and/or thermal hypersensitivity, and may include, for example, a pain type resulting from one or more conditions selected from peripheral injury pain, post-operative pain, cutaneous inflammation, cutaneous incision, muscle incision, or chronic pain. Disease states in which the disclosed methods may be used include fibromyalgia, sickle cell anemia, epidermolysis bullosa, erythromelalgia, complex regional pain syndrome, or generalized muscle pain.

What is claimed is: 
     
         1 . A method of treating pain in a mammal comprising the step of administering human growth hormone to said mammal. 
     
     
         2 . The method of  claim 1 , wherein said mammal is selected from a, a human neonate, a human child, a human juvenile, a human young adult, or a human adult. 
     
     
         3 . The method of  claim 1 , wherein said pain is caused by inflammation induced mechanical and/or thermal hypersensitivity. 
     
     
         4 . The method of  claim 1 , wherein said human growth hormone is administered to said mammal in an amount effective to treat a pain type resulting from one or more conditions selected from peripheral injury pain, post-operative pain, cutaneous inflammation, cutaneous incision, muscle incision, or chronic pain. 
     
     
         5 . The method of  claim 1 , wherein said human growth hormone is administered to treat pain associated with a disease or condition selected from fibromyalgia, sickle cell anemia, epidermolysis bullosa, erythromelalgia, complex regional pain syndrome, or generalized muscle pain. 
     
     
         6 . The method of  claim 1 , wherein said growth hormone is administered post-operatively. 
     
     
         7 . The method of  claim 1 , wherein said growth hormone is administered at a dose of from about 0.1 mg/kg to about 2.5 mg/kg, or from about 1 mg/kg to about 1.5 mg/kg. 
     
     
         8 . The method of  claim 1 , wherein said human growth hormone is administered at a time period selected from prior to an event likely to result in pain, at the time of the event likely to cause pain, or following an event likely to cause pain, or a combination thereof. 
     
     
         9 . The method of  claim 1  wherein said administration occurs prior to said event likely to cause pain, and wherein said administration occurs at a time period selected from about one day prior to said event, about two days prior to said event, or about three days prior to said event. 
     
     
         10 . The method of  claim 1 , wherein said dose is administered systemically, over a period of from 1 to 5 days, or 2 to 3 days, wherein if said dose is administered in a single day, said dose is from about 0.3 mg/kg to about 6 mg/kg. 
     
     
         11 . The method of  claim 1 , wherein said growth hormone is administered topically at a dose of from about 0.1 mg/kg to about 3 mg/kg, or from about 1 mg/kg to about 2 mg/kg. 
     
     
         12 . The method of  claim 1 , wherein said human growth hormone is administered to the site of cutaneous and/or muscular inflammation. 
     
     
         13 . The method of  claim 1 , wherein said administration is in an amount that avoids a side effect of human growth hormone administration selected from weight gain, transient fevers, hyperglycemia, or combinations thereof. 
     
     
         14 . The method of  claim 1 , wherein said administration of growth hormone prevents acute to chronic pain transition (a long term priming effect of an injury during development of said developing mammal to a subsequent re-injury as a young adult or adult; administration during a neonatal injury prevents altered DH neuron development and altered behavioral responsiveness to thermal and mechanical stimuli in adulthood; wherein said growth hormone is administered at a dose of about 1.5 mg/kg at the time of said injury. 
     
     
         15 . The method of  claim 1 , wherein said developing mammal does not have a systemic growth hormone deficiency. 
     
     
         16 . A method of preventing transition from acute to chronic inflammatory pain in a human subject, comprising the step of administering growth hormone to a subject immediately prior, during, or after an event likely to cause pain;
 wherein said growth hormone is administered to said human subject at a dose of from about 0.1 mg/kg to about 3 mg/kg, or from about 1 mg/kg to about 2 mg/kg;   wherein said human subject is a neonate, child, juvenile, or young adult.   
     
     
         17 . A kit comprising a composition comprising human growth hormone, and means for delivery of the composition to a human in need thereof. 
     
     
         18 . An article of manufacture comprising:
 a. a container comprising a label; and   b. a composition comprising growth hormone, wherein the label indicates that the composition is to be administered to a neonate, child, juvenile, or young adult, having, suspected of having, or at risk for developing, pain.   
     
     
         19 . The article of manufacture according to  claim 18 , wherein said pain results from one or more of cutaneous inflammation, cutaneous incision, or muscle incision. 
     
     
         20 . The article of manufacture of  claim 18 , wherein said label further indicates that the composition is to be administered to a neonate, child, juvenile, or young adult during, after, or prior to an event likely to cause pain resulting from one or more of cutaneous inflammation, cutaneous incision, or muscle incision, at a time period selected from at least one day prior, at least two days prior, or at least three days prior to said event.