Music as Analgesia During Neonatal Circumcision

Analgesia Clinical Trial

Official title:

Music as an Adjunct to Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252313
• Other study ID #: BIO-2018-0405
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: January 2020
• Source: American University of Beirut Medical Center
• Contact: Zavi Lakissian, MD, MPH, PgD
• Phone: 009611350000
• Email: zl00[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 48 Hours

Eligibility

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).

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• Music
Studies have been conducted to assess the effects of sound and noise on neonatal stress. Recently, music is being used in neonatal units to improve physiological and behavioral outcomes (Harling et al, 2009). Of the few studies done on the effectiveness of music during circumcision is a randomized double-blinded controlled trial conducted by Joyce et al (2001): it found that some physiologic outcomes were significantly lower among the music group in comparison to the EMLA group. They concluded that there is preliminary evidence to support the efficacy of EMLA and music in pain management of newborn circumcision; however, more rigorous studies are warranted for conclusive results.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (2)

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. — View Citation

Sharara-Chami et al. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial. Pediatrics. 2017;140(6):e20171935. Pediatrics. 2018 May;141(5). pii: e20180500. doi: 10.1542/peds.2018-0500. Epub 2018 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Infant Pain Scale (NIPS)	The NIPS is a non-intrusive, replicable, and objective tool for assessing pain responses. The tool uses five behavioral cues observed over time, with a composite score of 0 to 6, to determine the amount of pain or change in pain the infant is experiencing; scores more than 3 are indicative of pain.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Secondary	Heart Rate	The infant is placed on a pulse oximeter during the circumcision to monitor his heart rate.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Secondary	Oxygen Saturation	The infant is placed on a pulse oximeter during the circumcision to monitor his oxygen saturation.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.
Secondary	Crying Time	The assistant will be timing the infant's crying during the circumcision, as an indicator of pain.	4-6 minutes. Change of the infants pain during Stage 1-6 of the circumcision.