Skip to content

Feeling of pain to pinpricks in small babies

Neonatal pain response to various heel prick devices: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031863
Enrollment
180
Registered
2021-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: R448- Other symptoms and signs involvinggeneral sensations and perceptions

Interventions

Intervention1: Use of manual lancet for heel prick: Sterile and disposable 28-guage round lancet will be used for medically indicated heel prick for blood sampling. Lateral and medial aspects of unbru

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor
Sriparna Basu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Clinically stable neonates of gestational age >=28+0 weeks and birth weight >800g, requiring heel prick for blood sampling, during the first week of life

Exclusion criteria

Exclusion criteria: 1.Neonatal encephalopathy 2.Major intraventricular hemorrhage (grade III or IV) or other abnormality documented in cranial ultrasonography 3.Hemodynamic instability/shock 4. Patent ductus arteriosus 5. Mechanical ventilation 6. Major congenital malformations 7. Sedation or analgesia

Design outcomes

Primary

MeasureTime frame
Premature infant pain profile - Revised (PIPP-R) score during heel prickTimepoint: At the time of heel prick for blood sampling during first week of life

Secondary

MeasureTime frame
1.Changes in cerebral oxygenation (CrSO2) in near infra-red spectrometry values during procedure. 2.Duration of audible cry 3.Correlation of CrSO2 values with PIPP-R scores obtained in the study. 4.Difficulties encountered during the procedure (number of squeezes and pricks required for adequate sampling) and procedure related complications (bruising, inflammation and linear scar formation) Timepoint: At the time of heel prick for blood sampling during first week of life

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

drrisha.3004@gmail.com9971588402

Outcome results

None listed

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