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Recruitment was taking longer than originally anticipated.
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The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block. |
|
| Normal Saline | Placebo Comparator | Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sedation time | Evaluated upon completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Non-union | 1 month | |
| Need for re-manipulation | 1 week | |
| Adverse effects of sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Constantine, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasbro Children's Hospital/Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2015 | |
| Reset | May 20, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2015 | May 20, 2015 |
| ID | Term |
|---|---|
| D011885 | Radius Fractures |
| D014458 | Ulna Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Saline | Drug | Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL. |
|
|
| For the duration of the procedure |
| Adverse effects of hematoma block | 1 month |
| Pain control | For entire duration of procedure |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |