Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs
The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2018
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 8, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMarch 23, 2018
March 1, 2018
1 year
March 8, 2018
March 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
decrease pain
measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers
one week
Secondary Outcomes (1)
I.C.U stay time
one week
Study Arms (2)
morphine
ACTIVE COMPARATORThis group will receive only morphine infusion (20microgram/kg/h)
pregabalin
ACTIVE COMPARATORThis group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients above 18 years old
- ASA \[1\] and ASA \[2\]
- mentally competent and able to give consent for enrollment in the study
You may not qualify if:
- Patient coma scale less than 10
- Impaired kidney functions
- Chronic pain syndromes and patients with chronic opioid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Cannon RM, Smith JW, Franklin GA, Harbrecht BG, Miller FB, Richardson JD. Flail chest injury: are we making any progress? Am Surg. 2012 Apr;78(4):398-402.
PMID: 22472394BACKGROUNDKatz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
PMID: 8722735BACKGROUNDJensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PMID: 3785962BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 8, 2018
First Posted
March 22, 2018
Study Start
March 1, 2018
Primary Completion
March 1, 2019
Study Completion
April 1, 2019
Last Updated
March 23, 2018
Record last verified: 2018-03