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NCT06155825
Nonpharmacological Pain Management in Neonates
NA trial testing no intervention in Pain Management in 164 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Assiut University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 164 |
| Start date | 1 December 2023 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 February 2025 |
Drugs / interventions tested
- no intervention
- nonnutritive suckling — full drug profile →
- oral glucose 25%
- facilitated tuckling
Conditions studied
- Pain Management — all drugs for Pain Management →
- Neonates Pain Management — all drugs for Neonates Pain Management →
Sponsor
Assiut University
Who can join
32 Weeks and older, any sex, with Pain Management or Neonates Pain Management. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is A randomized controlled study which aim to: The primary aim in this study is assessment of non-pharmacological pain management in neonate and determine the most effective. The secondary aim of this study is to introduce idea of neonatal pain management. and record its effect on hospital stay and Duration to reach full enteral feeding. This prospective study will be conducted at NICU unit of Assiut University pediatrician hospital, Duration of study 1 year from 1/12/2023 to 1/12/2024. one hundred sixty-four children will be divided into 4 groups each group will have 41 patients. Groups 1-3 will be intervention groups, patients of which received a non-pharmacological intervention during mild regular painful maneuvers as cannula insertion, venipuncture, arterial puncture, heel prick, Group 1 will receive nonnutritive suckling. Group 2 will receive oral glucose 25% Group 3 will undergo facilitated tuckling Group 4 will be a control group (receive no nonpharmacological intervention). The pain response in each group will be assessed by CRIES score CRIES comes from (Crying, requires oxygen, Increased vital signs, Expression, Sleep). The scale may be taken over time to monitor the infant's (32 to 60 weeks' gestational age) recovery or response to interventions. Minimum score is 0 whilst maximum score is 10. The higher the score, the greater the expression of pain. If the CRIES score is greater than 4, further pain assessment should be undertaken, and analgesic administration is indicated for a score of 6 or higher.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06155825
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06155825 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assiut University
- Last refreshed: 4 December 2023
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