CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT

NCT02456142 | Completed Phase 4 DMC

• 1 other identifier: 206005358
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (2)

• time to first analgesic requirement

  time from intervention to pain score of 4

  24 hours

• 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

  24 hours

Secondary Outcomes (1)

• Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia

  24 hours

Study Arms (2)

caudal bupivacaine

EXPERIMENTAL

1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery

Drug: caudal bupivacaine

intravenous morphine

ACTIVE COMPARATOR

0.05mg/kg intravenous morphine given over 5 minutes

Drug: intravenous morphine

Interventions

caudal bupivacaine DRUG

Also known as: BUPICAN Heavy

caudal bupivacaine

intravenous morphine DRUG

intravenous morphine

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- All American Society of Anesthesia (ASA )I and II patients aged less than 8years undergoing elective abdominal perineal and lower limb orthopedic surgery

You may not qualify if:

• Known hypersensitivity to opioids Known hypersensitivity to local anesthetics

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago Hospital Complex

Kampala, Kampala, 256, Uganda

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• EZRA MUGISHA, MBChB

  makerere university college of health sciences department of anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: May 28, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2015-05

Locations

UG (1)