Pain
Conditions
Brief summary
Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional. OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline. STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial. POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period. OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score. Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
Interventions
OTHER30% glucose
Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
OTHERPlacebo
Male neonates will receive 2 ml of sterile water two minutes prior to circumcision
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age: 37 weeks-42 weeks * Birth weight: 2500 grams-4000 grams * Apgar scores a minimum of 7 at 1 and 5 minutes respectively * Heart rate between 100 and 160 per minutes * Blood O2 saturation of at least 95% * No recognized congenital abnormalities
Exclusion criteria
* They were transferred to the neonatal intensive care unit (NICU) * They required respiratory support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Pain will be assessed 1 minute before the procedure and during the procedure | Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 2 minutes before the procedure, during the procedure and one minute after the procedure | Heart rate (beats per minute) will be recorded |
| Respiratory rate | 2 minutes before the procedure, during the procedure and one minute after the procedure | Respiratory rate (breaths per minute) will be recorded |
| Oxygen saturation | 2 minutes before the procedure, during the procedure and one minute after the procedure | Oxygen saturation (in percent) will be recorded |
Countries
Lebanon
Contacts
Primary ContactAmal Naous, MD
Outcome results
None listed