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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02456142
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : April 11, 2016
Information provided by (Responsible Party):
Makerere University

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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: caudal bupivacaine Drug: intravenous morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: caudal bupivacaine
1ml/kg of 0.125% caudal bupivacaine given over 2 minutes will be given at the end of surgery
Drug: caudal bupivacaine
Other Name: BUPICAN Heavy

Active Comparator: intravenous morphine
0.05mg/kg intravenous morphine given over 5 minutes
Drug: intravenous morphine

Primary Outcome Measures :
  1. time to first analgesic requirement [ Time Frame: 24 hours ]
    time from intervention to pain score of 4

  2. Post- operative pain scores of the patients using age appropriate scales. [ Time Frame: 24 hours ]
    comparing the pain scores of the patients using the FLACC and the CRIES pain tools

Secondary Outcome Measures :
  1. Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia [ Time Frame: 24 hours ]
    watch for respiratory depression,anaphylaxis

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02456142

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Mulago Hospital Complex
Kampala, Uganda, 256
Sponsors and Collaborators
Makerere University
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Principal Investigator: EZRA MUGISHA, MBChB makerere university college of health sciences department of anesthesia
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Responsible Party: Makerere University Identifier: NCT02456142    
Other Study ID Numbers: 206005358
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid