Ketamine Patient-Controlled Analgesia for Acute Pain

• Sponsor: University of Cincinnati (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02062879
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain; Multiple Trauma; Fractures	Drug: Ketamine; Drug: Hydromorphone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Ketamine 90mg/30 mL PCA (3 mg/mL)	Drug: Ketamine; Ketamine administered as patient-controlled analgesia.; Other Names: Ketalar
Active Comparator: Hydromorphone Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)	Drug: Hydromorphone; Hydromorphone administered as patient-controlled analgesia.; Other Names: Dilaudid

Outcome Measures

Primary Outcome Measures

1. Total Daily Opioid Requirement [Participants will be followed for their entire hospital stay, an expected average of 1 week.]

   Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

Secondary Outcome Measures

1. Breakthrough Daily Opioid Requirement [Participants will be followed for their entire hospital stay, an expected average of 1 week]

   Breakthrough daily opioid requirement in milligrams of morphine equivalents/day

2. Median Pain Score [Participants will be followed for their entire hospital stay, an expected average of 1 week]

   Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age greater than or equal to 18 years

• Total Injury Severity Score greater than 9

• Functioning intravenous catheter present per standard of care

• Patient planned to receive PCA for acute pain per standard of care

• Patient ability to effectively use a PCA device as assessed by the primary attending trauma service

• Negative pregnancy test for women of childbearing age

Exclusion Criteria:

• Body mass index greater than 35

• History of active psychiatric disease

• Acute or chronic liver or renal failure

• History of heart failure or coronary artery disease

• Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy

• Patients who abuse alcohol and are at high risk for alcohol withdrawal

• Intubated patients

• Glasgow Coma Scale score less than 13, or motor subscore less than 6

• Documented allergy to ketamine, hydromorphone, or lorazepam

• Pregnancy

• Incarceration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• University of Cincinnati

Investigators

• Principal Investigator: Sheila C Takieddine, Pharm.D., UC Health
• Principal Investigator: Eric W Mueller, Pharm.D., UC Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheila Takieddine, Policy Development Specialist, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT02062879
• Other Study ID Numbers: Mueller2014
• First Posted: Feb 14, 2014
• Last Update Posted: Sep 21, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sheila Takieddine, Policy Development Specialist, University of Cincinnati: pain; trauma
• Additional relevant MeSH terms: Acute Pain; Wounds and Injuries; Multiple Trauma; Ketamine; Hydromorphone

Study Results

Participant Flow

Arm/Group Title	Ketamine	Hydromorphone
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Period Title: Overall Study
STARTED	10	10
COMPLETED	6	9
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Ketamine	Hydromorphone	Total
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	39	26	30
Sex: Female, Male (Count of Participants)
Female	3 30%	1 10%	4 20%
Male	7 70%	9 90%	16 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 20%	2 20%	4 20%
White	7 70%	8 80%	15 75%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 10%	0 0%	1 5%
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	27	26.5	27
Injury Severity Score (scores on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [scores on a scale]	29	28	29
Blunt Trauma (Count of Participants)
Count of Participants [Participants]	10 100%	9 90%	19 95%
Penetrating Trauma (Count of Participants)
Count of Participants [Participants]	0 0%	1 10%	1 5%

Outcome Measures

1. Primary Outcome

Title	Total Daily Opioid Requirement
Description	Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
Time Frame	Participants will be followed for their entire hospital stay, an expected average of 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Hydromorphone
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Measure Participants	10	10
Median (Inter-Quartile Range) [mg morphine equivalents/day]	10	42.5

2. Secondary Outcome

Title	Breakthrough Daily Opioid Requirement
Description	Breakthrough daily opioid requirement in milligrams of morphine equivalents/day
Time Frame	Participants will be followed for their entire hospital stay, an expected average of 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Hydromorphone
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Measure Participants	10	10
Median (Inter-Quartile Range) [mg morphine equivalents/day]	10	10

3. Secondary Outcome

Title	Median Pain Score
Description	Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.
Time Frame	Participants will be followed for their entire hospital stay, an expected average of 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Hydromorphone
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Measure Participants	10	10
Median (Inter-Quartile Range) [scores on a scale]	6.3	5.3

Adverse Events

Arm/Group Title	Ketamine		Hydromorphone
Arm/Group Description	Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.		Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
All Cause Mortality
	Ketamine		Hydromorphone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketamine		Hydromorphone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Ketamine		Hydromorphone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/10 (70%)		5/10 (50%)
Gastrointestinal disorders
Nausea	5/10 (50%)		3/10 (30%)
Psychiatric disorders
Hallucinations	4/10 (40%)		0/10 (0%)
Skin and subcutaneous tissue disorders
Pruritis	0/10 (0%)		4/10 (40%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.