Nebulized analgesia during laparoscopic appendectomy (NALA): A
randomized triple-blind placebo controlled trial
☆,☆☆,★,★★
Robert Baird
a,
⁎, Pablo Ingelmo
b
, Andrew Wei
b
, Yash Meghani
b
, Eduardo Vega Perez
b
, Helene Pelletier
a
,
Grant Auer
b
, Razaz Mujallid
b
, Sherif Emil
a
, Jean-Martin Laberge
a
, Pramod Puligandla
a
,
Kenneth Shaw
a
, Dan Poenaru
a
a
Department of Pediatric Surgery, The Montreal Children's Hospital, McGill University Health Centre
b
Department of Pediatric Anesthesia, The Montreal Children's Hospital, McGill University Health Centre
abstract article info
Article history:
Received 28 September 2018
Accepted 1 October 2018
Available online xxxx
Key words:
Appendicitis
Pain
Purpose: Postoperative pain remains a considerable concern for patients and families. We assessed whether
nebulized ropivacaine reduces morphine consumption and pain after laparoscopic appendectomy for uncompli-
cated appendicitis in children.
Methods: Patients 7–17 years old with uncomplicated appendicitis were randomized to ropivacaine (interven-
tion arm) or saline nebulization (placebo arm) at the onset of laparoscopy. Nonconsenting individuals were
treated with standard care and invited to provide clinical data (baseline arm). The primary outcome was in-
patient morphine utilization. Secondary outcomes included pain scores at multiple time-points, markers of re-
covery, operative times, and surgeon satisfaction. The trial was registered (NCT02624089).
Results: Study enrollment was 116 patients over a 1-year period: Intervention (n = 43), Placebo (n = 39), Base-
line (n = 34). No differences in baseline characteristics were noted between groups. No difference was noted in
overall in-patient morphine consumption between randomized groups (0.31 vs. 0.35 mg/kg, p = 0.42) or
between ropivacaine and baseline (0.31 vs. 0.277 mg/kg, p = 0.62). Although operative times were comparable
between groups, 63% of surgeon respondents felt that nebulization obscured visualization.
Conclusion: Nebulized ropivacaine did not reduce postoperative morphine consumption or pain scores after
laparoscopic appendectomy for simple appendicitis in children. Given that it decreases visualization and likely
increases costs, nebulized administration of intraperitoneal analgesia does not appear warranted in this context.
Type of study: Treatment study.
Level of evidence: Level I.
© 2018 Elsevier Inc. All rights reserved.
Appendicitis is the most common abdominal emergency in children,
and the fifth most common reason for childhood hospitalization in the
United States [1]. While there is considerable surgical literature
evaluating diagnostic algorithms, operative and postoperative care
and contemporary outcomes, there is extremely little written about
perioperative pain and analgesic strategies in this population. Pain is a
common and considerable concern for patients and families and may
decrease enthusiasm for surgical care when nonoperative options are
possible [2]. Intraperitoneal administration of nebulized anesthetic has
been described as safe and effective in adults undergoing a variety of
surgical procedures, but has not been evaluated in the pediatric popula-
tion or in the emergent setting [3].
We performed a randomized, triple-blinded placebo controlled trial
to assess whether nebulized ropivacaine reduces morphine consump-
tion and pain after laparoscopic appendectomy for uncomplicated
appendicitis in children. Secondary outcomes evaluated included the
intensity and duration of postoperative pain, the consumption of intra-
operative anesthetic agents, markers of recovery including time to
Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
☆ Author Contribution:Study conception and design: RB, PI, YM, RMAcquisition of data:
RB, AW, SE, JML, PP, KS, DP, PIAnalysis and interpretation of data: RB, AW, PIDrafting of
manuscript: RBCritical revision of manuscript: RB, SE, PP, DP, PI
☆☆ This research did not receive any specific grant from funding agencies in the public,
commercial, or not-for-profit sectors.
★ Aerogen (Galway, Ireland) provided the nebulization units without cost.
★★ How this paper will improve care: While postoperative discomfort remains a signifi-
cant concern for families and children undergoing appendectomy, intraabdominal nebu-
lized anesthetic during surgery did not improve pain or opioid consumption in this
context and may render the procedure more difficult to complete safely.
⁎ Corresponding author at: BC Children's and Women's Hospital, K0-134, 4480 Oak
Street, Vancouver, BC, V6H 3V4. Tel.: +1 604 875 2667; fax: +1 604 875 2721.
E-mail address: robert.baird@cw.bc.ca (R. Baird).
YJPSU-58877; No of Pages 6
https://doi.org/10.1016/j.jpedsurg.2018.10.029
0022-3468/© 2018 Elsevier Inc. All rights reserved.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery
journal homepage: www.elsevier.com/locate/jpedsurg
Please cite this article as: Baird R, et al, Nebulized analgesia during laparoscopic appendectomy (NALA): A randomized triple-blind placebo
controlled trial, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.029