Clinical trial NCT04252313: Music as Analgesia During Neonatal Circumcision
Official title: Music as an Adjunct to Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Keywords: Music
Neonatal Circumcision
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 206
Sex: MALE
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the control group \[Only EMLA+Sucrose+Ring Block\] or the Intervention \[EMLA+Sucrose+Ring Block+ Music\]
Primary purpose: SUPPORTIVE_CARE

Brief summary: Neonatal circumcision is one of the most frequently performed and more painful procedures. Sharara et al (2017) showed the combination of EMLA + Sucrose + Ring Block provides the highest standard of pain management. A combination which has been adopted by practitioners who perform circumcisions at the normal nursery at AUBMC. An element which is overlooked in its ability to enhance or suppress stress and consequently pain is sound/noise, music. The specific aim of this study is to test the added effectiveness of music (Group B: intervention) to the established standard for analgesia \[EMLA + Sucrose + Ring Block\] (Group A: control) in further managing the pain of newborn males undergoing circumcision.

Detailed description: Scientific Context: Neonatal circumcision is one of the most frequently performed and more painful procedures. Sharara et al (2017) showed the combination of EMLA + Sucrose + Ring Block provides the highest standard of pain management. A combination which has been adopted by practitioners who perform circumcisions at the normal nursery at AUBMC. An element which is overlooked in its ability to enhance or suppress stress and consequently pain is sound/noise, music.

Hypothesis/Aims: The specific aim of this study is to test the added effectiveness of music (intervention) to EMLA + Sucrose + Ring Block (control group) in further managing the pain of newborn males undergoing circumcision.

Experimental design, subject selection/recruitment, procedures involving human subjects: A double blinded randomized controlled trial, comparing the control Group A to the intervention Group B: Music. All healthy, late pre-term and term (36-41 weeks) newborn males admitted to the normal nursery at the AUBMC whose parents request circumcision are eligible for recruitment following a negative auditory screening test. Following written consent from the parents, participants will be allocated to either control or intervention based on a prepared list of block randomization. Babies will be videotaped during the circumcision, legs and the field of operation will be excluded from view. This video will be evaluated by two blinded pediatricians using the validated Neonatal Infant Pain Scale/Score (NIPS).

4- Risks and Benefits, and Risk/Benefit Ratio: The risks are associated with the circumcision procedure itself, not the proposed intervention, these risks are rare and may include risks associated with the surgery, or adverse reactions to the pharmacological anesthetics administered. Benefits include maximal pain management. The ratio leans favorably towards the benefits.

Privacy and Confidentiality: All Co-investigators are blinded to the randomization. Babies will be marked as Baby 1, Baby 2, and Baby 3...etc. The videotaping will not include any identifying information, although the baby's face will be in view; the videos will be placed on a password protected IPad only used for the purposes of this study, in the study coordinator's possession, kept in a locked drawer. When evaluating these videos, the evaluators will view them on the IPad. No copies or duplicates will be made and shared, even among the team. The collected data will be coded and kept on a password protected computer, the coded file will be shared with the statistician for the purposes of analysis. Following IRB protocol, all study related materials will be destroyed and permanently deleted after 3 years from the completion of the study.

Eligibility criteria: Inclusion Criteria:

* All healthy, late pre-term and term (36-41 weeks) newborn males admitted to the normal nursery at the American University of Beirut Medical Center (AUBMC) who have successfully passed an auditory screening (including the AABR and/or OAE) and whose parents request circumcision are eligible for recruitment

Exclusion Criteria:

* Newborn males admitted to the normal nursery at the American University of Beirut Medical Center (AUBMC), who have not passed the auditory screening (including the AABR and/or OAE).

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Secondary outcomes:
measure: Heart Rate
timeFrame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
measure: Oxygen Saturation
timeFrame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
measure: Crying Time
timeFrame: 4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Rana Sharara-Chami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
citation: Sharara-Chami et al. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial. Pediatrics. 2017;140(6):e20171935. Pediatrics. 2018 May;141(5):e20180500. doi: 10.1542/peds.2018-0500. Epub 2018 Apr 30. No abstract available.
citation: Sharara-Chami R, El-Hout Y, Lakissian Z, Hafez B, Abi-Gerges C, Fayad J, Charafeddine L, Tazian V, Tamim H, Zaghal A. Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial. J Pediatr Urol. 2022 Apr;18(2):184.e1-184.e6. doi: 10.1016/j.jpurol.2021.12.011. Epub 2021 Dec 24.