Intravenous Paracetamol versus Intravenous Diclofenac: Which is better in management of sickle cell children with vaso-occlusive Crisis (bone pain)

A Randomised Control Trial on Intravenous Acetaminophen versus Intravenous Diclofenac Sodium in Management of Sickle Cell Vaso-occlusive Crisis in Children

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011100

Enrollment

102

Registered

2018-01-02

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: null- Sickled children in both the arm were suffering from skeletal vaso-occlusive crisis and received the standard supportive care as per institutional protocol at time of recruitment

Interventions

Intervention1: Intravenous Acetaminophen: 7.5 mg to 15 mg per kg body weight administered in successive dose 8 hourly as per need assessment Control Intervention1: Intravenous Diclofenac sodium: 1 m

Eligibility

Inclusion criteria

Inclusion criteria: 1. HPLC Confirmed cases of sickle cell homozygous. 2. Clinically diagnosed cases of skeletal vaso-occlusive crisis.

Exclusion criteria

Exclusion criteria: 1. Critically ill children. 2. Cases having other serious complications of sickle cell disease apart from Skeletal Vaso Occlusive Crisis like acute chest syndrome, splenic sequestration, stroke ,overwhelming sepsis, osteomylitis, arthritis, etc.

Design outcomes

Primary

Measure	Time frame
Improvement in pain score Timepoint: After 60 minutes of infusion of drug	—

Secondary

Measure	Time frame
1. Total no of doses for pain relief / reduction. 2.Total duration of hospital stay in days. Timepoint: Till dischrge from hospital after 12 hour of pain free period	—

Countries

India

Contacts

Public ContactPrakash Chandra Pandda

Veer Surendra Sai Institute of Medical Sciences and Research (VIMSAR)

drnihar.mishra@gmail.com9337797072

Outcome results

None listed

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