Anaesthesia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Neonates between 1 to 28 days of age, scheduled for circumcision.
Exclusion criteria
Exclusion criteria: 1. Re-do Circumcisions. 2. Neonates with genitourinary anomalies such as Hypospaedias, Epispaedias, Disorders of Sex Development, Bladder exstrophy. 3. Neonates with family history of allergy to anaesthetic drugs or who had known allergy to Bupivacaine or related drugs 4. Neonates with coagulation disorders or hematological problems such as haemorrhagic disease of the newborn. 5. Failed Plastibell circumcision necessitating the use of other methods of circumcision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the analgesic efficacy of the two groups. 1. The time to first rescue analgesia, which is the time immediately after the circumcision to the time the neonate is given an oral ibuprofen due to onset of pain. 2. The duration of sensory block which is defined as time between injection of medication via DPNB and total abolition of pinprick response to the penile shaft. The procedure will start after the block is confirmed with no sensation felt and the duration of analgesia, will be defined as the time between total abolition of pin prick response and when patients had the rescue analgesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The mean pain scores in the two groups will be obtained four times and recorded into a proforma by the third research assistant, 30 minutes before procedure, during adhesiolysis, at the end of procedure, and 30 minutes post circumcision. 2. The haemodynamic changes in the two groups such as heart rate, respiratory rate, oxygen saturation, temperature. The patient’s heart rate, oxygen saturation, respiratory rate and temperature will be recorded four times, 30 minutes before the start of the procedure as the base line vital sign, during adhesiolysis, at the end of the procedure marked by the detachment of plastic handle after excision of the prepuce, and 30 minutes after the procedure. 3. Any other perioperative adverse effect of the circumcision related to both drugs upto 48 hours post procedure. | — |
Countries
Nigeria
Contacts
Dean of Faculty of Clinical Sciences University of Ibadan