Condition category
Haematological Disorders
Date applied
28/09/2009
Date assigned
26/10/2009
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.squ.edu.om/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes