Pain Managment in Preterm Neonates

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Preterm Neonates Pain Managment; PreTerm Neonate

Treatments: Drug: fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07148882

MS683/2023

Details and patient eligibility

About

To compare the effect of Intranasal versus Intravenous Fentanyl on oxidative stress by measuring MDA level just before and after 30 minutes from painful procedure and comparing the results.

Full description

1. Intra nasal fentanyl group: will receive intranasal fentanyl using nasal dose of INF is 1.5µg/kg/dose, and typically, one dose is given

   • After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure)

2. Intravenous fentanyl group: will receive intravenous fentanyl(1 µg/kg/dose) and typically, one dose is given •After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure) Measure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure Monitor adverse events after fentanyl use as apnea (cessation of breathing for >20 s), bradycardia (heart rate < 100 beats/minute), desaturation (oxygen saturation < 80%), and chest wall rigidity associated with laryngospasm (Pacifici, 2015) for 60 min after IN fentanyl administration.

Enrollment: 52 patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:• Preterm neonates during endotracheal intubation

-

Exclusion Criteria:o Contraindication of fentanyl use as hypersensitivity.

• Contraindication of nasal administration of drugs as bilateral occluded nasal passage as choanal atresia and Epistaxis.
• Surgical patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

52 participants in 2 patient groups

intravenous fentanyl

Active Comparator group

Description:

Intravenous fentanyl group: will receive intravenous fentanyl(1 µg/kg/dose) and typically, one dose is givenMeasure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure

Treatment:

Drug: fentanyl

intranasal fentanyl

Active Comparator group

Description:

Intra nasal fentanyl group: will receive intranasal fentanyl (@fentanyl hamein 50mic/1ml, manufactured by sunny pharmaceutical) using nasal dose of INF is 1.5µg/kg/dose, and typically, one dose is given (Kaushal et al., 2020). Measure MDA (Malondialdehyde ) level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure

Treatment:

Drug: fentanyl