NCT04479215

Brief Summary

This study is aimed to only observe the feeding practices after surgery in children undergoing below umbilicus surgery in day care and any impact of length of fasting on vomiting after surgery. If the child meets the criteria for being included in this study, the parents will be provided with informed consent form at the time of arrival at the daycare unit or at the time of arrival in the waiting area of the operating room. If parents agree and sign the consent form, then the child will be included in the study. The length of fasting period after the surgery and any episode of vomiting from after surgery till discharge time to home, will be recorded on a printed form. The nature of this study is only observation and the child will not be subjected to any new technique or medications. Parents will also be contacted on the next day of surgery on the phone number for any further observation about the child's feeding and vomiting and parental satisfaction with the anesthesia given will also be asked.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 10, 2020

Last Update Submit

July 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative feeding practice

    adverse outcomes after restarting feeding postoperatively will be assessed

    immediately after surgery to 24 hours after surgery

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children aged between 2-10 years of age and ASA (American Society of Anesthesiologist) classification I or II, undergoing infra-umblical daycare surgery under general anesthesia combined with caudal block will be enrolled in the study.

You may qualify if:

  • Pediatrics patients undergoing infra-umbilical elective daycare surgery under general anesthesia combined with caudal block
  • Age group 2 years to 10 years
  • ASA (American Society of Anesthesiologist) classification I or II

You may not qualify if:

  • Pediatric patient who would require postoperative fasting for surgical reasons
  • Patients with any known digestive pathology predisposing to post-operative vomiting (e.g. hiatal hernia and gastro-esophageal reflux)
  • Patients receiving anti-emetic medications during the intraoperative period
  • Patients receiving opioids during the intraoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Rizalar S, Ozbas A. Effect of Early Postoperative Feeding on the Recovery of Children Post Appendectomy. Gastroenterol Nurs. 2018 Mar/Apr;41(2):131-140. doi: 10.1097/SGA.0000000000000279.

    PMID: 29596127BACKGROUND
  • Radke OC, Biedler A, Kolodzie K, Cakmakkaya OS, Silomon M, Apfel CC. The effect of postoperative fasting on vomiting in children and their assessment of pain. Paediatr Anaesth. 2009 May;19(5):494-9. doi: 10.1111/j.1460-9592.2009.02974.x.

    PMID: 19453581BACKGROUND
  • Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.

    PMID: 28203729BACKGROUND
  • Liechti M, Feurer R, Gross D, Schmitz A, Stutz K, Gerber A, Weiss M. Prevention of postoperative nausea and vomiting in children following adenotonsillectomy, using tropisetron with or without low-dose dexamethasone. J Anesth. 2007;21(3):311-6. doi: 10.1007/s00540-007-0523-0. Epub 2007 Aug 1.

    PMID: 17680180BACKGROUND
  • Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children. Anesth Analg. 2007 Dec;105(6):1592-7, table of contents. doi: 10.1213/01.ane.0000287816.44124.03.

    PMID: 18042855BACKGROUND
  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

    PMID: 26757238BACKGROUND
  • Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.

    PMID: 30877144BACKGROUND
  • Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.

    PMID: 27746521BACKGROUND
  • Marulasiddappa V, Nethra HN. A Survey on Awareness about the Role of Anesthesia and Anesthesiologists among the Patients Undergoing Surgeries in a Tertiary Care Teaching Women and Children Hospital. Anesth Essays Res. 2017 Jan-Mar;11(1):144-150. doi: 10.4103/0259-1162.186595.

    PMID: 28298774BACKGROUND
  • Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27.

    PMID: 29700894BACKGROUND
  • Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.

    PMID: 27166876BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 21, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

July 21, 2020

Record last verified: 2020-07