Trials / Completed
CompletedNCT02803723
"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Centre Hospitalier Universitaire de la Réunion · Academic / Other
- Sex
- All
- Age
- 3 Months
- Healthy volunteers
- Not accepted
Summary
"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants. Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units. Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Holding-cuddling | The "Holding-cuddling" is started 5 minutes before veinipuncture. |
| PROCEDURE | Sucrose | The sucrose adminstration is started 2 minutes before veinipuncture. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2016-06-17
- Last updated
- 2020-02-11
Source: ClinicalTrials.gov record NCT02803723. Inclusion in this directory is not an endorsement.