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PubMed1996

Dose-response curve of human extensor digitorum brevis muscle function to intramuscularly injected botulinum toxin type A.

To develop a human model for measuring the effect of intramuscularly injected botulinum toxin, we injected both extensor digitorum brevis (EDB) muscles in 13 healthy volunteers with seven varying doses of botulinum toxin type A. We measured, pre- and postinjection, EDB M-wave amplitude, area, and mean rectified voltage (MRV) (obtained during maximal voluntary muscle activation). There was a logarithmic-appearing dose-response relationship between increasing doses of botulinum toxin and decline in EDB M-wave amplitude, area, and MRV. The decline was incrementally less at higher doses of toxin and appeared to level off at a maximal effect of 85 to 90% decrement from baseline (85 to 90% "paralysis") at 15 to 20 units. The peak toxin effect was present on day 6 postinjection. Measurement of EDB M-wave amplitude, area, and MRV is a simple objective method for quantifying the onset and degree of human muscle "paralysis" following botulinum-toxin injection.

Adult↗
PubMed1983

Pharmacokinetics of a single intramuscular injection of vitamin E to premature neonates.

The pharmacokinetics of parenterally administered vitamin E (d, l-alpha tocopherol) in serum were developed using data from five premature neonates (1,500 +/- 100 gm) receiving a single 20 mg/kg intramuscular injection. Blood samples were obtained immediately prior to drug administration to establish baseline vitamin E concentrations: then further sampling was performed at various intervals for up to 7 days. It was assumed that dietary intake of vitamin E did not markedly alter serum concentration of vitamin E during the 7-day study and that the total intramuscular dose was absorbed. Although extensive sampling could not be performed in any one neonate, composite sampling from the study population made it possible to construct a pharmacokinetic profile of vitamin E in premature neonates. The half-life of elimination was 44 hours, the volume of distribution (V beta) was 0.41 liter/kg. and serum clearance was 6.5 ml/hr/kg. Vitamin E is an important biological antioxidant that may provide protection to the retinas and lungs of premature infants exposed to supplemental inspiratory oxygen. Therefore, if the pharmacokinetics of vitamin E observed in the present study can be generalized to the population of premature infants, a single 10 mg/kg intramuscular (IM) loading dose followed by 5 mg/kg every 48-72 hours should maintain serum concentration of 1.5 to 2.5 mg%--a level that has been associated with antioxidant protection.

Female↗
PubMed2004

Patient-controlled analgesia versus conventional intramuscular injection: a cost effectiveness analysis.

BACKGROUND: In previous studies comparing patient-controlled-analgesia and intramuscular pain management have been unable to provide conclusive evidence of the benefits of either method of postoperative pain control. AIM: The purpose of the study was to compare the efficacy and cost-effectiveness of intravenous patient-controlled-analgesia with intermittent intramuscular morphine for Chinese women in the first 24 hours following elective gynaecological surgery. METHODS: A randomized control design was used. The main outcomes were level of pain and cost for the two types of pain management. Participants indicated their level of pain at rest and when deep breathing or coughing on a 100 mm Visual Analogue Scale, on seven occasions within 24 postoperative hours. Costs for the two types of pain management were based on the costs of equipment, drugs and nursing time. RESULTS: A total of 125 women participated in the study. Mean pain level over the 24 hours in the patient-controlled-analgesia group was significantly lower than in the intramuscular group (P < 0.001). Mean pain level over the seven occasions for the patient-controlled-analgesia group was 11.83 points (95% CI 7.14-16.52) lower when at rest and 11.73 points (95% CI 5.96-17.50) lower during motion than the intramuscular group. Cost per patient was $81.10 (Hong Kong) higher for patient-controlled-analgesia than for intramuscular pain management. Women in the patient-controlled-analgesia group had significantly greater satisfaction with pain management than those in the intramuscular group (P < 0.001), but reported significantly more episodes of nausea (P < 0.05). CONCLUSIONS: While patient-controlled-analgesia was more costly, it was also more effective than conventional on-demand intramuscular opioid injections after laparotomy for gynaecological surgery.

Adolescent↗
PubMed1991

Transmission of hepatitis B virus infection by iatrogenic intramuscular injections in an endemic area.

The authors followed 95 people from the general and aboriginal population of Taiwan, aged 5 to 69 years for two years. All of subjects studied were susceptible to hepatitis B virus (HBV) infection. In all, 56 of the 95 persons received iatrogenic intramuscular (IM) injections, and 28 of the 95 became newly infected with HBV during the study period. The relative risk of being infected with HBV was higher in people who received an IM injection (IRR = 5.8, 95% CI 1.9-17.9) than in those who did not. New HBV infections were found to correlate significantly with the frequency of injections (Ptrend less than 0.000) and therefore, we concluded that (A) intramuscular injections played an important role in horizontal transmission of HBV, particularly among Aborigines and that (B) the infection was transmitted via inadequately sterilized syringes used for iatrogenic IM injections in a community in which the hepatitis B virus was prevalent and IM injections were common.

Adolescent↗
PubMed1987

Menstrual regulation by intramuscular injections of 16-phenoxy-tetranor PGE2 methyl sulfonylamide or vacuum aspiration. A randomized multicentre study. World Health Organization Task Force on Post-ovulatory Methods for Fertility Regulation.

A multicentre trial was conducted to compare the efficacy and side-effects of an intramuscularly administered PGE2 analogue and vacuum aspiration in women with a delay of up to 21 days in the expected onset of menses. A total of 473 such women were randomly allocated to treatment with either 16-phenoxy-W-17, 18, 19, 20-tetranor PGE2 methyl sulfonylamide (three intramuscular injections of 0.5 mg at 3-h intervals) or vacuum aspiration, and the outcome of therapy assessed 1, 2 and 6-8 weeks later. Retrospective analysis of hCG levels indicated that 419 (88.6%) women had been pregnant at the time of treatment. With few exceptions, administration of the PGE2 analogue induced vaginal bleeding in both pregnant and non-pregnant women but the duration and subjectively perceived amount of bleeding were greater than after vacuum aspiration. Both treatments were equally effective. In pregnant women the overall frequency of complete abortion was 91% for prostaglandin treatment and 94% for vacuum aspirations. If non-pregnant women were included, the respective success rates (i.e. percentages of women not pregnant 2 weeks after treatment) were 92% and 95%. Gastrointestinal side-effects and lower abdominal pain requiring intramuscular analgesia were more common after prostaglandin therapy than following vacuum aspiration in both pregnant and non-pregnant women.

Abortifacient Agents↗
PubMed1977

Extraosseous osteogenic sarcoma following an intramuscular injection.

A 29-year-old white male with an extraosseous osteogenic sarcoma is reported. He first noted a nodule at the site of eventual tumor development some eight years previously, following an intramuscular penicillin injection. Treatment consisted of wide surgical excision and radiation therapy, and he remains healthy some 8 months later. To our knowledge this represents the first case of extraosseous osteogenic sarcoma occurring at the site of a previous intramuscular injection.

Adult↗
PubMed1997

Long-term erythropoietin expression in rodents and non-human primates following intramuscular injection of a replication-defective adenoviral vector.

Erythropoietin (Epo)-responsive anemia is a debilitating complication of chronic renal failure and human immunodeficiency virus (HIV) infection that effects more than 150,000 Americans. Patients with Epo-responsive anemias are currently treated with repeated injections of recombinant human Epo. In the studies described in this report, we have examined the safety and efficacy of using a single intramuscular (i.m.) injection of replication-defective adenoviral vectors (RDAd) encoding Epo for the treatment of Epo-responsive anemias in both mice and non-human primates. Our results demonstrate that there is a threshold dose of virus (2.5-8 x 10(7) pfu/gram of body weight) which is required to obtain long-term Epo expression and polycythemia in both species. A single i.m. injection of mice with 10(9) pfu of an RDAd encoding murine Epo (AdmEpo) resulted in elevations in hematocrits from control values of 49 +/- 0.9% to treated values of 81 +/- 3%, which were stable for more than 1 year. Similarly, a single i.m. injection of a monkey with 4 x 10(11) pfu of an RDAd-encoding simian Epo (AdsEpo) resulted in elevations of hematocrits from control levels of 40% to treated levels of > or =70%, which were stable for 84 days. Intramuscular injection of monkeys with AdsEpo appeared to be safe in that we did not detect abnormalities in chest X-rays, serum chemistries, hematologic, or clotting profiles (apart from elevated hematocrits) or organ histologies during the 84-day time course of the experiment. Taken together, these results suggest the feasibility of using i.m. injection of RDAd for the treatment of Epo-responsive anemias in humans.

Adenoviridae↗
PubMed2000

Immune rejection of human dystrophin following intramuscular injections of naked DNA in mdx mice.

Intramuscular administration of plasmid expressing full-length human dystrophin in dystrophin-deficient adult mdx mice resulted in humoral and weak specific T cell responses against the human dystrophin protein. Following plasmid injection, human dystrophin was detected in the injected muscles at 7 days, but decreased thereafter. Anti-dystrophin antibodies were found 21 days following plasmid injection, which coincided with transient myositis. This immune rejection prevented the mice from expressing human dystrophin after a second plasmid injection. No anti-DNA antibodies were found. Anti-dystrophin antibodies were seen in a smaller proportion of plasmid-injected dystrophin-competent C57BL/10 mice, suggesting that the immune rejection of dystrophin may be explained partially by species differences in the dystrophin protein.

Animals↗
PubMed2003

Intramuscular injection of AAV-GDNF results in sustained expression of transgenic GDNF, and its delivery to spinal motoneurons by retrograde transport.

Adeno-associated virus (AAV) vector has been developed as an attractive gene delivery system with proven safety. Glial cell line-derived neurotrophic factor (GDNF) is proposed to be a promising therapeutic agent for amyotrophic lateral sclerosis (ALS) and other motor neuron diseases. The purpose of this report was to investigate transgenic GDNF expression at different time points post AAV mediated GDNF intramuscular delivery. An AAV vector was constructed to encode a recombinant fusion of GDNF tagged with a FLAG sequence at the C-terminal (AAV-GDNF) to distinguish it from its endogenous counterpart. A single intramuscular injection of AAV-GDNF led to substantial expression of transgenic GDNF which remained for at least 10 months in transduced gastrocnemius muscle. This transgenic GDNF was distributed in a large number of myofibers, mainly in the vicinity of the sarcolemma and predominantly concentrated at the sites of neuromuscular junctions (NMJs). Furthermore, transgenic GDNF, but not beta-galactosidase expressed as a control, was detected in the motoneurons that projected axons to the injected muscles, thus, indicating retrograde axonal transportation of the transgenic GDNF. This study provides a basis for a strategy of intramuscular AAV-GDNF delivery to protect motoneurons as a possible means of ALS treatment.

Animals↗
PubMed2000

Histological and histochemical alterations in the liver following intramuscular injection with a sublethal dose of the Egyptian cobra venom.

In the present study, the effects of intramuscular (i.m.) injection of a sublethal dose (0.015 microgram/gm b.wt.) of Naja haje venom were histologically and histochemically examined in the hepatic tissues of rabbits after 3, 6, and 12 hr. of envenomation. Three hours after venom injection, the hepatic cells showed a generalized cytoplasmic granulation and cellular swelling accompanied with narrowing of the sinusoidal spaces. Occurrence of inflammatory cells and hypertrophy of Kupffer cells were also noticed. After 6 hr. of envenomation, the hepatic tissues revealed severe cellular swelling, cytoplasmic deterioration, nuclear pyknosis, and appearance of numerous basophilic granules. The central veins were engorged with hemolyzed blood. Hepatic tissues investigated after 12 hr. of envenomation exhibited highly damaged hepatic cells to the extent that the individual cell cannot be identified and remnants of cell debris were seen intermixed together. Some hepatic cells were intensively swollen and their contents were dissoluted except for a few dusty cytoplasmic granules and pyknotic nuclei. The histochemical observations showed a time dependent depletion in polysaccharide, lipid, and protein contents in the hepatic cells of the envenomed groups. As for the nucleic acids, slight depletion of RNA together with no changes in DNA contents were observed by 3 hr. of envenomation. Nevertheless, severe degrees of RNA depletion and moderate contents of DNA were recorded in 6 hr. envenomed tissues. Highly obvious depletion of RNA and DNA were demonstrated by 12 hr. after venom injection. From the above results, it is obvious that cobra venom induces a hepatotoxic action reflected by alterations in the histological and histochemical patterns of the hepatic tissues. These alterations are initiated at early stages of envenomation and could indicate a disturbance in the functional activities of the liver during envenomation.

Animals↗
PubMed1988

Hypoglycaemia in childhood diabetes. II. Effect of subcutaneous or intramuscular injection of different doses of glucagon.

Hypoglycaemia (blood glucose 1.3-2.5 mmol/l) was induced in thirty diabetic children by reduction of their morning meal. Glucagon, 10 or 20 micrograms/kg was then given by intramuscular or subcutaneous injection. Ten min later, all signs of hypoglycaemia had disappeared and blood glucose concentrations increased by 0.7-3.3 mmol/l. Glucagon plasma concentrations at glucose nadir were low, 23 +/- 8 pmol/l, rose to 300 +/- 42 ten min after the injection and reached peak values after another ten min. Later, a slow decrease was noted. No significant difference of blood glucose or plasma glucagon concentrations were found after subcutaneous or intramuscular injections of 20 micrograms/kg. After 10 micrograms/kg, slightly lower increase of blood glucose was seen, but the clinical effect was equally good. Nausea occurred in four children given 20 micrograms/kg. The rise of blood glucose did not correlate to the peak glucagon concentration obtained after the injection but showed significant correlations to the lowest glucose concentration and, inversely, to the concentration of free insulin in blood at glucose nadir. It is concluded that glucagon injections are effective in hypoglycaemia in insulin-treated diabetic children and that the injection of 10-20 micrograms/kg gives long-standing supraphysiological concentrations which make repeated injections unnecessary.

Adolescent↗
PubMed1990

Distribution of material injected intramuscularly in dogs.

A radiopaque marker was injected, using needles of various lengths, into the cervical musculature, the lumbar epaxial musculature, and the cranial and caudal muscular masses of the thighs of anesthetized dogs. After this procedure, the dogs were euthanatized and deep-frozen. The bodies were then sectioned, and the slices were radiographed to determine the fate of the injected material. Material that was injected into the neck or caudal region of the thigh was determined to be located in the muscle bellies or dispensed throughout the intermuscular fascial sheaths. In contrast, material injected into the lumbar area and cranial region of the thigh was located entirely in the muscle bellies. It was concluded that the best sites for injection in dogs are the lumbar epaxial musculature or the quadriceps femoris muscle when IM administration is imperative.

Animals↗
PubMed1976

Behavior maintained under a second-order schedule by intramuscular injection of morphine or cocaine in rhesus monkeys.

Three rhesus monkeys lived in primate cages provided with response keys and enclosed in isolation chambers. During experimental sessions on Monday, Wednesday and Friday, the chamber door was closed and every 10th key-pressing response during a 60-minute interval produced a 2-second red light, but had no other programmed consequences (the 10-response fixed-ratio component of the second-order schedule; FR 10). The first FR 10 component completed after the 60-minute interval had elapsed produced a red light which remained on for 2 minutes while the chamber door was opened; the monkey then extended his arm and was given an intramuscular injection of drug (the 60-minute fixed-interval component of the second-order schedule; FI 60 min). Under this second-order schedule of intramuscular drug injection, repeated sequences of rapid responding were maintained during each session by 0.75 to 3.0 mg/kg injections of either morphine or cocaine. Patterns of responding characteristic of FR schedules were controlled by the 2-second red lights; a pause in responding after each 2-second red light was followed by a sustained high rate of responding until the light was produced again. Pauses in responding became progressively shorter as time elapsed in the 60-minute interval. When saline injections were substituted for drug injections, responding markedly decreased. When responding was maintained by 3.0 mg/kg morphine injections, pretreatment with 0.03 mg/kg of nalorphine increased responding, while pretreatment with 0.1 or 0.3 mg/kg of nalorphine decreased responding.

Animals↗
PubMedDate not supplied

Investigation of the pharmacokinetics and analgesic effects of an intramuscular injection of sustained-release sufentanil for postoperative pain: an open study.

STUDY OBJECTIVES: To investigate the pharmacokinetics after an intramuscular (IM) injection of sufentanil in thin vegetable oil in postsurgical patients and to determine whether sustained-release IM sufentanil can provide safe and sufficient analgesia of long duration in these patients. DESIGN: Open study. SETTING: University hospital. PATIENTS: 10 ASA physical status I and II patients aged 18 to 65 years who were scheduled for elective surgery. INTERVENTIONS: All patients were premedicated with lorazepam and anesthetized with a general anesthetic technique containing nitrous oxide, fentanyl, and isoflurane. As soon as significant pain [visual analog scale score of 5 or greater (range, 0 = no pain to 10 = worst pain imaginable)] occurred during the early postoperative period, the patient received an IM injection of sustained-release sufentanil. MEASUREMENTS AND MAIN RESULTS: During the first 48 hours following surgery, blood samples were taken for determination of plasma sufentanil concentrations. Blood pressure, heart rate, respiratory rate, pain scores, and sedation scores were documented at the same time. The IM administration of sufentanil in thin vegetable oil provided sufficient pain relief, although the onset of analgesia was rather slow (+/- 1 hour). The analgesic effect was still apparent 48 hours later. Plasma concentration of sufentanil at the different time points varied from 0.021 to 0.142 ng/ml, with a mean maximal peak concentration of 0.103 ng/ml. The plasma concentration 48 hours after injection varied from 0.026 to 0.074 ng/ml. CONCLUSIONS: Although an IM injection of sufentanil in thin vegetable oil is effective for postoperative pain relief, it is associated with wide interindividual variability in plasma concentration of sufentanil and long duration of action.

Adolescent↗
PubMed2002

Lack of an immune response against the tetracycline-dependent transactivator correlates with long-term doxycycline-regulated transgene expression in nonhuman primates after intramuscular injection of recombinant adeno-associated virus.

We previously documented persistent regulation of erythropoietin (Epo) secretion in mice after a single intramuscular (i.m.) injection of a recombinant adeno-associated virus (rAAV) vector harboring both the tetracycline-dependent transactivator (rtTA) and the Epo cDNA (D. Bohl, A. Salvetti, P. Moullier, and J. M. Heard, Blood 92:1512-1517, 1998). Using the same vector harboring the cynomolgus macaque Epo cDNA instead, the present study evaluated the ability of the tetracycline-regulatable (tetR) system to establish long-term transgene regulation in nonhuman primates. The vector was administered i.m., after which 5-day induction pulses were performed monthly for up to 13 months by using doxycycline (DOX), a tetracycline analog. We show that initial inductions were successful in all individuals and that there was a tight regulation and a rapid deinduction pattern upon DOX withdrawal. For one macaque, regulation of Epo secretion was maintained during the entire experimental period; for the five remaining macaques, secreted Epo became indistinguishable from endogenous Epo upon repeated DOX inductions. We investigated the mechanism involved and showed that, except in the animal in which secretion persisted, delayed humoral and cellular immune responses were directed against the rtTA transactivator protein associated with the reduction of vector DNA in transduced muscles. This study provides some evidence that, when the immune system is not mobilized against the rtTA transactivator, the tetR-regulatable system is able to support long-term transgene regulation in the context of an rAAV in nonhuman primates. In addition, our results suggest potential improvements for vector design.

Animals↗
PubMedDate not supplied

Lymphatic delivery and pharmacokinetics of methotrexate after intramuscular injection of differently charged liposome-entrapped methotrexate to rats.

The lymph node targeting ability and pharmacokinetics of methotrexate (MTX) after intramuscular (i.m.) injection of differently charged liposome-entrapped [3H]MTX to rats were evaluated using [3H]MTX as a tracer. Neutral liposomes were prepared with a mixture of phosphatidylcholine, cholesterol and alpha-tocopherol (8:4:0.1, molar ratio). Positively and negatively charged liposomes were also prepared by incorporation of stearylamine (8:4:0.1, molar ratio) and dicetylphosphate (8:4:0.1:1, molar ratio) into neutral liposomes respectively. The encapsulation efficiency (as expressed in terms of radioactivity) in liposomes was increased as alpha-tocopherol was incorporated into the lipid bilayer. The disappearance of [3H]MTX from the i.m. injection site was rapid and essentially complete after 30 min. On the other hand, the disappearance of radioactivity of liposome-entrapped [3H]MTX was much slower when compared to free drug. The area under the drug concentration-time curve (AUC) of liposome-entrapped [3H]MTX in lymph nodes was significantly increased when compared to free [3H]MTX. It suggested that liposomes injected by the i.m. route entered into the lymphatics and only drug released from liposomes diffused directly into the systematic circulation. The liposome-entrapped [3H]MTX by i.m. route was markedly localized in the lymph nodes. The concentration of MTX-equivalents in regional lymph node after i.m. injection of liposome-entrapped [3H]MTX was > 100-350 fold higher when compared to the plasma concentration. These values are more than 10-20 fold higher compared to the i.m. injection of free [3H]MTX. The positively charged liposomes were more localized in lymph nodes compared to neutral and negatively charged ones. While liposomes injected by i.v. route were localized in liver, spleen and lung compared to free [3H]MTX, it was evident that i.m. administration of liposomes resulted in enhanced localization of MTX in the lymphatic system but decreased deposition in kidney, liver and other non-targeting tissues compared to free [3H]MTX. The targeting ability and carrier properties of liposome-entrapped anticancer drugs with varying surface charge, lipid compositions and route of administration are of significant importance to alter biodistribution in chemotherapy.

Animals↗
PubMed2001

Kinematic and kinetic evaluation of the ankle after intramuscular injection of botulinum toxin A in children with cerebral palsy.

Intramuscular botulinum toxin A (BTA) injection has a role in the conservative management of dynamic equinus deformity in children with cerebral palsy. The effect of BTA injection of the gastrocsoleus muscle during gait was evaluated. Eight children with hemiplegia (median age 4.4 years, range 2 to 8 years) were included in this retrospective study. Assessment included kinematic and kinetic gait analysis before and after (median 57.5 days) treatment. Postinjective kinematics showed significant improvement of ankle range of motion in the stance phase of gait. Ankle kinetics demonstrated a significant decrease of pathological power generation in midstance. The ankle power quotient (APQ) was also significantly improved. Ankle power in terminal stance was improved, although not to a significant level. These results provide evidence of normalization of energy production at the ankle, which is critical for normal gait. The effect of BTA is temporary and can be successfully repeated. This allows deferring the need for surgical intervention until the child is older and recurrence rate is lower.

Ankle Joint↗