Patient Re-education vs. Background Morphine to IV-PCA in Patient With Unsatisfactory Analgesia Post Laparotomy
Information source: Clinical Research Centre, Malaysia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-operative Pain
Intervention: morphine (Drug); Patient re-education (Behavioral)
Phase: Phase 4
Status: Recruiting
Sponsored by: Clinical Research Centre, Malaysia Official(s) and/or principal investigator(s): lee choo yeoh, master, Principal Investigator, Affiliation: CRC Malaysia
Overall contact: Lee Choo Yeoh, Master, Phone: 047722625, Email: yeohlc55@yahoo.com
Summary
The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique
for postoperative analgesia. Investigators are comparing between patient re-education and
the background morphine infusion among patients who fail to achieve satisfactory analgesia
using IV-PCA Morphine after laparotomy.
Clinical Details
Official title: Comparing Effectiveness of Post-operative Analgesia Between Patient Re-education and the Additional of a Basal Morphine Infusion to IV-PCA Morphine in Patients With Unsatisfactory Analgesia After Laparotomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
Secondary outcome: respiratory ratetotal accumulative morphine consumption from IV-PCA pump sedation level
Detailed description:
In this study, investigators have a second inclusion criteria for subject recruitment. For
subjects who meet this criteria meaning their dynamic pain (when blowing incentive
spirometer) is ≥ 4/10 after starting on IV-PCA Morphine will be randomized in to 2 groups.
One group will receive patient re-‐education with an additional background morphine infusion
and the other group will receive re-‐education only.
The second highlight for this study is regarding the background morphine calculation. The
background morphine is calculated according to this formula:
Total morphine requirement in the first 24 hours post surgery (mg) = 100 - Age (year) So,
the background morphine infusion will be calculated based on subject's age and half of their
24 hours requirement will be infused over 24 hours.
This formula was published by Pamela Macintyre in her paper titled " Age is the Best
Predictor of Postoperative Morphine Requirement".
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- American Society of Anesthesiologists (ASA)Physical Status Classification Class I and
II
- Elective laparotomy
- able to understand either malaysia, mandarin, english language or local dialect
- patient with dynamic pain score 4/10 and more within the first 4-hour after
initiation of IV-PCA
Exclusion Criteria:
- patient refusal
- laparotomy with pfannenstiel incision
- patients with a history of allergy to opioids
- patients who required post-operative ventilation support
- patients ASA III and above
- patients unable to use PCA due to insufficient comprehension
- morbid obesity/ obstructive sleep apnea
- chronic opioid or alcohol abuse
Locations and Contacts
Lee Choo Yeoh, Master, Phone: 047722625, Email: yeohlc55@yahoo.com
Sultanah Bahiyah Hospital, Alor Seatr, Kedah 05050, Malaysia; Recruiting yeoh lc, Phone: 047722625, Email: yeohlc55@yahoo.com
Additional Information
Starting date: August 2015
Last updated: August 14, 2015
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