Use of Intravenous Paracetamol in Combination with Morphine in sickle cell disease children with vaso-occlusive crisis

ISRCTN	ISRCTN34491330
DOI	https://doi.org/10.1186/ISRCTN34491330
Secondary identifying numbers	310

Submission date: 28/09/2009
Registration date: 26/10/2009
Last edited: 26/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yasser Wali
Scientific

AL-Khoud
Sultanate of Oman
Muscat
123
Oman

Email	yasser_wali@hotmail.com

Study information

Study design	Single-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	IPCM
Study objectives	To look for any reduction in the amount of morphine and duration of hospitalisation as a result of using intravenous (IV) paracetamol.
Ethics approval(s)	Approved by the Medical Research and Ethics Committee of Sultan Qaboos University, Oman (ref: 310)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2008
Completion date	01/05/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	13 Years
Sex	Both
Target number of participants	200
Key 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)
Key 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
Date of first enrolment	01/05/2008
Date of final enrolment	01/05/2010

Locations

Countries of recruitment

Oman

Study participating centre

AL-Khoud

Muscat
123
Oman

Sponsor information

Sultan Qaboos University (Oman) - College of Medicine and Health Sciences
University/education

AL-Khoud
Sultanate of Oman
Muscat
123
Oman

Website	http://www.squ.edu.om/
"ROR"	https://ror.org/049xx5c95

Funders

Funder type

University/education

Sultan Qaboos University (Oman) - College of Medicine and Health Sciences

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan