CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT (CaBuMorph)
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
Uganda
Study Type
Interventional
Intervention
caudal bupivacaine
intravenous morphine
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- All American Society of Anesthesia (ASA )I and II patients aged less than 8years undergoing elective abdominal perineal and lower limb orthopedic surgery
Exclusion Criteria:
- Known hypersensitivity to opioids Known hypersensitivity to local anesthetics
Sites / Locations
- Mulago Hospital Complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
caudal bupivacaine
intravenous morphine
Arm Description
1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery
0.05mg/kg intravenous morphine given over 5 minutes
Outcomes
Primary Outcome Measures
time to first analgesic requirement
time from intervention to pain score of 4
Post- operative pain scores of the patients using age appropriate scales.
comparing the pain scores of the patients using the FLACC and the CRIES pain tools
Secondary Outcome Measures
Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia
watch for respiratory depression,anaphylaxis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456142
Brief Title
CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT
Acronym
CaBuMorph
Official Title
EFFECT OF CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT IN PEDIATRIC SURGICAL PATIENTS; A RANDOMISED CONTROLLED TRIAL.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pain is a subjective sensation which in children can only be experienced and most times not expressed. Pain management in children thus falls short of their adult counterparts. Acute pain of surgery causes significant suffering and stress. In children, pain management has lagged behind because of the belief that children's pain receptors are less well developed than their adult counterparts. However this has been proven to be false as development of pain receptors has been shown by 26th week of gestation. Caudal analgesia with plain bupivacaine has been used for effective post operative analgesia. Resources sometimes limit acquisition of additives to bupivacaine to be delivered into the intrathecal space.
The fear of pharmacological adverse effects of opioids has restricted their use especially among the anesthesia officers who deliver the bulk of anesthesia services in Uganda and this has led to poor pain management in pediatric populations Mulago national referral hospital is a resource limited centre with regards to human resource, equipment and drugs. This is mainly due to lack of sufficient funds and large volume of patients with the nursing staff being overwhelmed by the patient capacity. Drug administration is often not done on time and continuous assessment of pain scores in children is not adequate resulting in poor post operative pain management. Pain control thus will depend on analgesia provided at the time of operation creating a need for prolonged pain control measures.
Studies done have compared intravenous morphine administration versus caudal analgesia and are mostly focused of sub umbilical surgery however none has been done in our setting. Bupivacaine and morphine are now more readily available and can be used for post operative analgesia. However studies on the timing to the next analgesic requirement have not been compared/done in Mulago national referral hospital.
Detailed Description
Patients will be wheeled into the operating theatre.
Anaesthesia will be induced using an inhalation anaesthetic (sevoflurane) and intravenous anaesthetic using propofol or thiopental for the older children (3 years and above).
Maintenance of anaesthesia will be done using either inhalation anaesthetic (sevoflurane)
Intra-operative analgesia will be maintained with intravenous fentanyl given at the start of surgery and hourly for surgeries longer than one hour.
Monitoring intra and post operatively will be done with WHO standard monitoring. (Blood pressure, heart rate, saturation, temperature, ECG, End tidal carbon dioxide).
The intervention will be given at the end of surgery after the last stitch has been placed with patient receiving either caudal bupivacaine or intravenous morphine.
to receive a caudal the baby will be placed in the left lateral position knees and hips flexed
The skin over the coccyx and sacrum will be cleansed with povidone-iodine solution and alcohol.
After palpation of the sacral cornua, a 22- or 23-gauge needle will be placed into the sacral hiatus to identify the epidural space by loss of resistance as the needle passes through the sacral ligament.
Aspiration will be done to check for cerebrospinal fluid or blood, then a test dose is administered to rule out intravenous injection then the drug caudal bupivacaine will be injected.
The patients' pain scores will be assessed by the research assistant in the post anaesthesia care unit after 30 minutes before being discharged to their parent wards and hourly after the intervention is given.
monitoring of pulse rate and saturation on the ward will be done with a pulse oximeter.
On the ward the pain scores will be assessed every hour by the research assistant and time to a pain score of 4 recorded
The pain scores and the time to the next analgesic requirement will be recorded and continuation of analgesia given with intravenous paracetamol.
The crying, requires oxygen, increased vital signs, expression, sleeplessness (CRIES) pain tool will be used to score pain in neonates and the Face, Legs, Activity, Cry and Consolability (FLACC) pain score used in children above 2 months. Analgesic requirement will be given if child found to be in pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
caudal bupivacaine
Arm Type
Experimental
Arm Description
1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery
Arm Title
intravenous morphine
Arm Type
Active Comparator
Arm Description
0.05mg/kg intravenous morphine given over 5 minutes
Intervention Type
Drug
Intervention Name(s)
caudal bupivacaine
Other Intervention Name(s)
BUPICAN Heavy
Intervention Type
Drug
Intervention Name(s)
intravenous morphine
Primary Outcome Measure Information:
Title
time to first analgesic requirement
Description
time from intervention to pain score of 4
Time Frame
24 hours
Title
Post- operative pain scores of the patients using age appropriate scales.
Description
comparing the pain scores of the patients using the FLACC and the CRIES pain tools
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia
Description
watch for respiratory depression,anaphylaxis
Time Frame
24 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All American Society of Anesthesia (ASA )I and II patients aged less than 8years undergoing elective abdominal perineal and lower limb orthopedic surgery
Exclusion Criteria:
Known hypersensitivity to opioids Known hypersensitivity to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EZRA MUGISHA, MBChB
Organizational Affiliation
makerere university college of health sciences department of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital Complex
City
Kampala
ZIP/Postal Code
256
Country
Uganda
12. IPD Sharing Statement
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CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT
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