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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201307308391N2 |
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Date of registration:
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2013-08-11 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Acute abdominal Postoperative Pain Control in children
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Scientific title:
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A comparison of effect of caudal block and wound infiltration with bupivacaine in acute postoperative pain control in children after elective lower abdominal surgery with general anesthesia |
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Date of first enrolment:
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2013-08-23 |
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Target sample size:
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55 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/8869 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Mehrsima Abdollahzadeh
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Address:
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Namjoo street,Alzahra hospital
Rasht
Iran (Islamic Republic of) |
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Telephone:
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+98 13 1321 0434 |
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Email:
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vbuh.research@gmail.com,mehrsima@yahoo.com,ARC@gums.ac.ir |
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Affiliation:
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Guilan University of Medical Sciences |
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Name:
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Mehrsima Abdollahzadeh
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Address:
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Namjoo St.,Alzahra hospital
Rasht
Iran (Islamic Republic of) |
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Telephone:
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+98 13 1321 0434 |
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Email:
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mehrsima49@yahoo.com, ARC@gums.ac.ir,vbuh.research@gmail.com |
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Affiliation:
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Guilan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria : 2-8 years old patient with ASA class I-II under elective lower abdominal surgery (aug 2013 - aug 2014)
Exclusion criteria : ASA class III- IV , urgent surgery , sensitivity to local anesthetics , G6PD deficiency , coagulation disorder , localized infection , parents refusal, pre-existing neurologic disorder
Exclusion criteria:
Age minimum:
2 years
Age maximum:
8 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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acute postoperative pain.
Acute pain
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Acute pain
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Intervention(s)
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control group : caudal analgesia with 1ml/kg bupivacaine 0/25%
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Intervention 1: intervention group : wound infiltration with 0/5 ml/kg bupivacaine 0/25% into the edges of the wound after fascial closure. Intervention 2: control group : caudal analgesia with 1ml/kg bupivacaine 0/25%.
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intervention group : wound infiltration with 0/5 ml/kg bupivacaine 0/25% into the edges of the wound after fascial closure.
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Prevention
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Primary Outcome(s)
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Acute postoperative pain. Timepoint: 1-6-12-24 hour after procedure. Method of measurement: modified objective pediatric pain scale(0-10).
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Secondary Outcome(s)
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Duration of analgesia provided by technique. Timepoint: hour/min after surgery. Method of measurement: interval between administration of the first dose of rectal acetaminophen and prucedure.
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Amount of rectally received acetaminophen. Timepoint: 1,6,12,24 hour after surgery. Method of measurement: total dosage(mg) and the number of times received rectal acetaminophen.
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Urine retention - bowel activity. Timepoint: 1,6,12,24 hour after surgery. Method of measurement: time intrval of first urination / bowel activity from prucedure.
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Parents satisfaction. Timepoint: 1-6-12-24 hour after procedure. Method of measurement: satisfaction score(0-3) {0=not at all satisfied, 1=not satisfied, 2= partially satisfied, 3= satisfied}.
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Source(s) of Monetary Support
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Guilan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Guilan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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