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Efficacy of Intravenous versus Intramuscular Injection of Tramadol for Sickle Cell Vaso-occlusive Crisis

Continuous Intravenous Infusion versus Intermittent Intramuscular Injection of Tramadol for Sickle Cell Vaso-occlusive Crisis: An Open Label Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019359
Enrollment
80
Registered
2019-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D570- Hb-SS disease with crisis

Interventions

Intervention1: Continuous Intravenous Infusion versus Intermittent Intramuscular Injection of Tramadol: 1.intravenous continuous infusion of tramadol dose- 0.25mg/kg/hr. 2.intramuscular intermittent t

Sponsors

VIMSAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-diagnosed case of sickle cell disease with vaso-occlusive crisis both homozygous and compound hetrerozygous(by HPLC study) 2-VOC will be diagnosed if the patient present with pain involving skeleton, chest, abdomen or all three lasting 4hours or more. 3-moderate to severe grade of VOC (VISUAL ANALOGUE SCALE)

Exclusion criteria

Exclusion criteria: 1- cases associated with diabetes mellitus, stroke, peripheral vascular disease, polycythemia that are likely to modify viscosity of blood. 2- contraindication for tramadol. 3- critically ill patients including acute chest syndrome.

Design outcomes

Primary

MeasureTime frame
Study may throw light on efficacy of continuous intravenous of tramadol for the treatment of vaso-occlusive crises in sickle cell disease patients.Timepoint: 1year 6 months

Secondary

MeasureTime frame
1-onset of pain relief 2- breakthrough pain 3- use of adjuvant 4- adverse effect 5- degree/ duration of pain relief 6- cumulative dose since pain reliefTimepoint: 1 year 6 months

Countries

India

Contacts

Public ContactDR BALADEV PRASAD KAR

VSS Institute of Medical Science & Research

drpradeepmohanty@rediffmail.com9439990242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026