Contact information
Type
Scientific
Primary contact
Dr Yasser Wali
ORCID ID
Contact details
AL-Khoud
Sultanate of Oman
Muscat
123
Oman
yasser_wali@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
310
Study information
Scientific title
Efficacy of intravenous paracetamol in combination with opiod infusion for sickle cell disease children in vaso-occlusive crisis: a single-blinded randomised trial
Acronym
IPCM
Study hypothesis
To look for any reduction in the amount of morphine and duration of hospitalisation as a result of using intravenous (IV) paracetamol.
Ethics approval
Approved by the Medical Research and Ethics Committee of Sultan Qaboos University, Oman (ref: 310)
Study design
Single-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sickle cell disease with vaso-occlusive crisis
Intervention
Use of IV paracetamol in combination with morphine versus use of placebo with morphine:
Group A (standard treatment): morphine (weight of the child multiplied by constant 0.5 = *mg of morphine) and placebo (50 ml of starch/dextromaltose, one hour duration, six hourly)
Group B (intervention treatment): morphine infusion and intravenous paracetamol infusion. Morphine dose is calculated as in group A, and dose of paracetamol will be 15 mg/kg/dose every six hourly in a one hour infusion.
Duration of treatment depends on the response of the pain; no standard period. The period of hospital stay will be compared later to see if there is any reduction by adding IV paracetamol to morphine treatment. The patient will have liver function tests performed at the beginning of the treatment to establish a baseline, and then the patient will be followed up in the out-patient clinic.
*mg of morphine is added to 50 ml 5% dextrose. 1 ml/hr is equal to 10 µg/kg/hr. The starting rate is 5 ml/hr which is equal to 50 µg/kg/hr. The rate is titrated according to the response of pain.
Intervention type
Drug
Phase
Not Specified
Drug names
Morphine, intravenous (IV) paracetamol
Primary outcome measure
Reduction in the amount of morphine and duration of hospitalisation, assessed on a daily basis.
Secondary outcome measures
Assessed on a daily basis:
1. Reduction in duration of hospital stay (days) for pain relief
2. Reduction in pain severity on a scale of 1 - 10, which will be assessed each shift
3. Reduction of morphine requirements
4. Reduction in morphine side effects namely: prurities, nausea/vomiting, urinary retention
Overall trial start date
01/05/2008
Overall trial end date
01/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All sickle cell disease (SCD) children (aged 2 - 13 years, either sex) admitted with vaso-occlusive crisis (VOC) in B2 (blue two) ward of Sultan Qaboos University Hospital (SQUH)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Children aged less than one year
2. Children with fever of more than 38.5°C
3. Children with prior side effects of morphine
4. Children with prior history of side effects of paracetamol
5. Children with severe jaundice or severe liver impairment
Recruitment start date
01/05/2008
Recruitment end date
01/05/2010
Locations
Countries of recruitment
Oman
Trial participating centre
AL-Khoud
Muscat
123
Oman
Sponsor information
Organisation
Sultan Qaboos University (Oman) - College of Medicine and Health Sciences
Sponsor details
AL-Khoud
Sultanate of Oman
Muscat
123
Oman
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Sultan Qaboos University (Oman) - College of Medicine and Health Sciences
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list