Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose group | Experimental | Neonates will receive 30% oral glucose |
|
| Placebo group | Placebo Comparator | Neonates will receive sterile water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30% glucose | Other | Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | 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. | Pain will be assessed 1 minute before the procedure and during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate (beats per minute) will be recorded | 2 minutes before the procedure, during the procedure and one minute after the procedure |
| Respiratory rate | Respiratory rate (breaths per minute) will be recorded |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal Naous, MD | Contact | +9611636000 | 6317 | amalnaous@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amal Naous, MD | Makassed General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Recruiting | Beirut | Lebanon |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Male neonates will receive 2 ml of sterile water two minutes prior to circumcision |
|
| 2 minutes before the procedure, during the procedure and one minute after the procedure |
| Oxygen saturation | Oxygen saturation (in percent) will be recorded | 2 minutes before the procedure, during the procedure and one minute after the procedure |