Ultrasound Guided Pain Control Versus Standard Treatment in Emergency Department HIP Fracture Patients

• Sponsor: Antonios Likourezos (Other)
• Overall Status: Completed
• CT.gov ID: NCT01904071
• Collaborator: Emergency Medicine Foundation (Other)
• Enrollment: 64
• Location: 1
• Arms: 3
• Duration (Months): 22
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Hip Fracture (HFx) is a painful injury that is often treated in the Emergency Department (ED) with intravenous opiates. However, this class of medications may cause deleterious side effects. An alternative analgesic approach involves regional anesthesia. The investigators attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNBs) could be safely performed in an ED setting, (2) whether UPNBs would be more effective than standard treatment in controlling pain from HFx and (3) which of two UPNBs was superior for pain relief.

A convenience sample of patients with an isolated HFx and a pain score > 5/10 were enrolled and randomized to one of three arms: (1) Ultrasound guided 3-in-1 femoral nerve block (UFNB), (2) Ultrasound guided fascia iliaca compartment block (UFIB), or (3) IVMS. Patients indicated their pain from 0 (no pain) to 10 (extreme pain).

Condition or Disease	Intervention/Treatment	Phase
Hip Fracture	Procedure: UFNB (Ultrasound guided femoral nerve block); Procedure: UFIB (Ultrasound Guided Fascia Iliaca Compartment Block); Drug: IVMS (IV Morphine)	Phase 4

Detailed Description

Hip fracture (HFx) is a painful orthopedic emergency that commonly presents to the Emergency Department (ED). There are approximately 320,000 HFx diagnosed annually in the United States, with this number expected to increase as the population ages. It has previously been shown that patients with pain from HFx are undermedicated while in the ED, particularly in overcrowded facilities. Current treatment for ED patients who are experiencing pain from acute HFx is often with intravenous morphine sulfate (IVMS). Morphine can have many undesirable side effects, but of particular concern are delirium, hypotension and respiratory depression. These complications may be accentuated in elderly patients and may necessitate increased patient monitoring and greater utilization of limited ED resources.An alternative to systemic opioid analgesia involves peripheral nerve blockade. Anesthesiologists frequently perform nerve blocks in the peri-operative and post-operative period to control pain in patients undergoing hip surgery. Traditionally, nerve stimulators were used to place the nerve block. However, ultrasonography is being used with increasing frequency to facilitate placement of these peripheral nerve blocks. As Emergency Physicians (EP) become more facile with the use of bedside sonography, ultrasound guided peripheral nerve blockade for HFx may be ideally suited for the ED environment, where one injection could control pain for many hours. The 3-in-1 femoral nerve block (FNB), in which anesthetic is injected adjacent to the femoral nerve but also affects the lateral femoral cutaneous and the obturator nerves, has been shown to be as effective as morphine for pain control of HFx in the ED. Sonographic guidance has been shown to increase the success rate of this block, decrease the time to analgesia, decrease the amount of local anesthetic needed to achieve adequate regional anesthesia, and decrease the incidence of inadvertent intravascular injection.

To date, there has been limited research describing the utilization of ultrasound guided femoral nerve blocks in an ED setting. Beaudoin et al. performed a feasibility study demonstrating that EP could effectively perform ultrasound guided femoral nerve blocks. Reid et al. found a significantly decreased time to complete analgesia when using sonographic guidance compared to an anatomic landmark technique. In this later study, anesthesia was assessed by checking skin sensation. Neither of these studies utilized a 3-in-1 nerve block, which may provide greater pain relief for patients with HFx.

The fascia iliaca compartment block (FIB) is also effective for treating pain due to HFx. It has been shown in the pediatric anesthesia and pediatric emergency medicine literature that it provides adequate analgesia, and may provide more effective analgesia than the FNB for femur fractures in children. Most of the studies describe the FIB being performed using a technique based on anatomic landmarks. One recent study described ultrasound guidance of the FIB (UFIB) increasing the efficacy of the sensory blockade (12). UFIB has not previously been studied in the ED setting.

We attempted to determine (1) whether ultrasound guided peripheral nerve blocks (UPNB) could be safely performed in an ED setting, (2) whether UPNB would be more effective than standard treatment in controlling pain from HFx in which a 2.5 unit decrease in pain scores was considered clinically significant, and (3) which of two UPNB was superior for pain relief.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrasound Guided Femoral (3 in 1) Nerve Block Versus Ultrasound Guided Fascia Iliacus Compartment Block Versus Standard Treatment for Pain Control in Patients With Hip Fractures in the Emergency Department
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UFNB Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.	Procedure: UFNB (Ultrasound guided femoral nerve block); Ultrasound Guided Femoral Nerve Block
Experimental: UFIB Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.	Procedure: UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)
Active Comparator: IVMS IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg	Drug: IVMS (IV Morphine); Intravenous Morphine

Outcome Measures

Primary Outcome Measures

1. Pain Score at 30 Minutes [30 minutes]

   Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Secondary Outcome Measures

1. Pain Score at 60 Minutes [60 minutes]

   Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Other Outcome Measures

1. Pain Score at 120 Minutes [120 minutes]

   Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

2. Pain Score at 240 Minutes [240 minutes]

   Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

3. Pain Score at 480 Minutes [480 minutes]

   Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. English speaking patients

2. ≥18 years of age

3. radiographic evidence of hip fracture

4. Patients must be awake, alert and oriented to time, place and person.

5. pain score of ≥ 5 in 10 point scale.

Exclusion Criteria:

1. cognitive deficits

2. allergic to amide-type local anesthetic or morphine

3. more injuries than just hip fracture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Antonios Likourezos
• Emergency Medicine Foundation

Investigators

• Principal Investigator: Eitan Dickman, MD, Maimonides Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.
• Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. Epub 2007 May 3.
• Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13. Erratum in: Anesth Analg 1990 Apr;70(4):474.
• Department of Health and Human Services, the Centers for Disease control, 2004
• Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31.
• Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33.
• Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8.
• Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006 Feb;54(2):270-5.
• Marhofer P, Schrögendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7.
• Marhofer P, Schrögendorfer K, Wallner T, Koinig H, Mayer N, Kapral S. Ultrasonographic guidance reduces the amount of local anesthetic for 3-in-1 blocks. Reg Anesth Pain Med. 1998 Nov-Dec;23(6):584-8.
• Reid N, Stella J, Ryan M, Ragg M. Use of ultrasound to facilitate accurate femoral nerve block in the emergency department. Emerg Med Australas. 2009 Apr;21(2):124-30. doi: 10.1111/j.1742-6723.2009.01163.x.
• Wathen JE, Gao D, Merritt G, Georgopoulos G, Battan FK. A randomized controlled trial comparing a fascia iliaca compartment nerve block to a traditional systemic analgesic for femur fractures in a pediatric emergency department. Ann Emerg Med. 2007 Aug;50(2):162-71, 171.e1. Epub 2007 Jan 8.

• Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT01904071
• Other Study ID Numbers: 08/09/VA09
• First Posted: Jul 22, 2013
• Last Update Posted: Jun 6, 2018
• Last Verified: May 1, 2014

• Keywords provided by Antonios Likourezos, Research Manager, Maimonides Medical Center: Hip Fracture; Ultrasound; Nerve Block
• Additional relevant MeSH terms: Emergencies; Fractures, Bone; Hip Fractures; Morphine

Study Results

Participant Flow

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Period Title: Overall Study
STARTED	24	20	20
COMPLETED	24	20	20
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	UFNB	UFIB	IVMS	Total
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)	Total of all reporting groups
Overall Participants	24	20	20	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82 (9.96)	82 (7.74)	85 (7.91)	83 (8.64)
Sex: Female, Male (Count of Participants)
Female	17 70.8%	11 55%	13 65%	41 64.1%
Male	7 29.2%	9 45%	7 35%	23 35.9%
Region of Enrollment (participants) [Number]
United States	24 100%	20 100%	20 100%	64 100%
Pain Score at Triage (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.17 (3.29)	5.50 (3.99)	6.98 (1.87)	5.84 (3.23)

Outcome Measures

1. Primary Outcome

Title	Pain Score at 30 Minutes
Description	Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Measure Participants	24	20	20
Mean (Standard Deviation) [units on a scale]	1.94 (2.43)	2.05 (2.61)	5.13 (2.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UFNB, UFIB, IVMS
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Pain Score at 60 Minutes
Description	Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Measure Participants	24	20	20
Mean (Standard Deviation) [units on a scale]	2.58 (3.06)	1.90 (2.38)	4.40 (2.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UFNB, UFIB, IVMS
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	ANOVA
	Comments

3. Other Pre-specified Outcome

Title	Pain Score at 120 Minutes
Description	Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

Pain score was not obtained for one patient in the IVMS group at 120 minutes.

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Measure Participants	24	20	19
Mean (Standard Deviation) [units on a scale]	2.65 (2.49)	1.30 (1.89)	4.00 (2.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UFNB, UFIB, IVMS
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.005
	Comments
	Method	ANOVA
	Comments

4. Other Pre-specified Outcome

Title	Pain Score at 240 Minutes
Description	Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Time Frame	240 minutes

Outcome Measure Data

Analysis Population Description

Pain score was not obtained for one patient in the UFNB group at 240 minutes

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Measure Participants	23	20	20
Mean (Standard Deviation) [units on a scale]	3.15 (2.70)	1.72 (1.98)	4.83 (2.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UFNB, UFIB, IVMS
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	ANOVA
	Comments

5. Other Pre-specified Outcome

Title	Pain Score at 480 Minutes
Description	Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain
Time Frame	480 minutes

Outcome Measure Data

Analysis Population Description

Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes

Arm/Group Title	UFNB	UFIB	IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)	Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)	IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
Measure Participants	20	17	17
Mean (Standard Deviation) [units on a scale]	3.20 (2.28)	2.35 (3.07)	3.74 (2.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UFNB, UFIB, IVMS
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.342
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	240 minutes
Arm/Group Title	UFNB		UFIB		IVMS
Arm/Group Description	Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery. UFNB (Ultrasound guided femoral nerve block)		Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle. UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)		IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg IVMS (IV Morphine)
All Cause Mortality
	UFNB		UFIB		IVMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	UFNB		UFIB		IVMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	UFNB		UFIB		IVMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.