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A clinical trial to study effect of local pain relieving agent and position during lumbar puncture on success rate of the lumbar puncture procedure in neonate

Lumbar puncture in sitting versus lateral recumbent position with or without use of topical anaesthetic agent in neonates: A factorial randomized control trial. - EPTALS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006280
Enrollment
236
Registered
2015-10-19
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- Suspected sepsis or any condition warranting CSF study

Interventions

Intervention1: sitting,placebo: 1 gm of placebo to be applied Route- on skin over lumbar area Duration- for 1 hour under tight occlusion. Dosage-1gm to be applied once per baby in a 48 hour period

Sponsors

Sir Ganga Ram Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates admitted in NICU who are planned to undergo lumbar puncture as decided by the treating physician.

Exclusion criteria

Exclusion criteria: Intraventricular hemorrhage Mechanical ventilation Neonatal encephalopathy Congenital anomaly Neural tube defects vertebral defects Other gross congenital anomalies Local skin inflammation or infection or exudative skin lesion. Cardiovascular instability Surgery in preceding 7 days Received muscle relaxants, sedatives & analgesia during previous 24 hours Failure to obtain consent

Design outcomes

Secondary

MeasureTime frame
1.Physiological parameters: heart rate, transcutaneous oxygen saturation and PCO2 2.Pain scores assessed as per PIPP score 3.Occurrence of adverse skin reaction like blanching, rashes, erythema, purpuric lesion at site of application 4.Number of attempts taken for successful lumbar punctureTimepoint: 24 hour after end of procedure

Primary

MeasureTime frame
Successful lumbar puncture defined as obtaining a non-hemorrhagic CSF (grossly clear CSF and/or CSF RBC count 1000/mm3)Timepoint: immediately at end of lumbar puncture- 0 min at end of lumbar puncture

Countries

India

Contacts

Public ContactDr Susanta Kumar Badatya

Sir Ganga ram Hospital

satishsaluja@gmail.com098110477389

Outcome results

None listed

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