Actively Recruiting
Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery: a Before-and-after Chart Review Study
Led by Karolinska Institutet · Updated on 2025-12-12
150
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cleft lip and palate (CLP) is a common birth condition that often requires multiple surgeries during childhood. These surgeries can cause significant pain afterward, traditionally managed with opioids like morphine, which may lead to side effects. Researchers are studying whether introducing a specific nerve block called the suprazygomatic maxillary nerve block (SZMNB) can reduce the need for opioid pain medicines and shorten hospital stays after cleft palate surgery. This study compares two groups of children aged 3 months to 15 years who had cleft palate surgery between 2017 and 2018. One group received standard pain medications including opioids, acetaminophen, and NSAIDs, while the other group also received the SZMNB nerve block as part of their care. This is a retrospective observational study using medical records from before and after the introduction of SZMNB to examine differences in pain management and recovery. Participants' medical records are reviewed for age, sex, surgery details, pain treatments, pain scores, opioid use, side effects like nausea and sedation, and length of hospital stay. The main measure is how long children stayed in the hospital after surgery, with secondary measures including total opioid use, need for extra pain relief, opioid side effects, and pain scores assessed with validated scales. The study aims to improve understanding of pain control and recovery in children undergoing cleft palate repair.
CONDITIONS
Brief Title
Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 months to 15 years
- Underwent cleft palate surgery between 2017 and 2018
- Have complete and available medical records including surgery, anesthesia, and discharge notes
- Received either standard systemic analgesia alone or with suprazygomatic maxillary nerve block (SZMNB)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are identified through medical record review; no visits required.
Duration - Hospital stay of approximately 5 days
Participants undergo cleft palate surgery and receive either standard systemic analgesia alone or combined with a suprazygomatic maxillary nerve block (SZMNB) as part of routine perioperative care.
Care and assessments occur during hospitalization
Duration - Up to 5 days post-surgery
Participants’ postoperative pain, opioid consumption, supplemental analgesic needs, and side effects are monitored during the hospital stay.
Pain assessments occur from surgery baseline to 24 hours postoperatively
Trial Site Locations
Total: 1 location
1
Stockholm, Sweden, SE-171 76
Actively Recruiting
Research Team
J
Jacob KarlssonM, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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