Pain and hypoxia in premature neonates

Pain and hypoxia in premature neonates: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49512764

Enrollment

260

Registered

2015-05-21

Start date

2009-02-25

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Procedural pain in premature neonates Signs and Symptoms Acute pain

Interventions

1. Intervention group: sucrose 24% and non-nutritive sucking 2. Control group: placebo and non-nutritive sucking

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Premature infants 800 grams 2. Have an arterial or central line catheter in place 3. Require endotracheal suctioning or heel lance

Exclusion criteria

Exclusion criteria: 1. Unstable oxygenation and hemodynamic status due to persistent pulmonary hypertension (PPHN) 2. Cyanotic heart disease 3. Severe respiratory distress 4. Septic shock 5. Taking medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin 6. Intraventricular hemorrhage grade 3 or more 7. Seizures 8. Facial or multiple congenital anomalies that may alter pain behavior

Design outcomes

Primary

Measure	Time frame
1. Pain score 2. Plasma concentration of hypoxanthine, xanthine, uric acid and allantoin	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

United States of America

Outcome results

None listed

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