72 Clinical Trials for Various Conditions
Tonsillectomy is one of the most common surgeries performed in the United States, with over half a million performed annually in children younger than 15 years of age. Postoperative pain is one of the most common clinical problems and may lead to poor intake, dehydration, and weight loss. Management of postoperative pain is often challenging and results in additional medical costs due to unplanned emergency room visits. Opioids such as codeine are commonly prescribed for pain control, however in 2013 the Food \& Drug Administration issued a black box warning for the use of codeine in post-tonsillectomy pediatric patients. The American Academy of Otolaryngology-Head and Neck Surgery recommends the use of acetaminophen and ibuprofen to successfully manage postoperative pain. With an extended recovery period, often longer than 7 days, alternative measures to reduce postoperative pain are needed. Honey has been proven to possess antibacterial and anti-inflammatory properties. This intervention will evaluate the effect of Tylenol, ibuprofen with honey on children's postoperative pain and nausea following tonsillectomy surgery.
The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair.
The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.
The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Postoperative pain management in the pediatric patient undergoing tonsillectomy is challenging. Despite being used in many procedures for postoperative pain management, perioperative ketorolac usage in pediatric tonsillectomy surgery is very limited. A recent survey showed that only 8.2% of anesthesiologists use NSAIDS for perioperative management of children with OSA undergoing adenotonsillectomy. The investigators propose to conduct a prospective, randomized study to investigate the opioid-sparing effect of perioperative ketorolac in pediatric patients who undergo tonsillectomies.
The purpose of this study is to determine if methadone improves postoperative pain control in pediatric patient's undergoing cardiac surgery.
1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery. 2. The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
The purpose of this prospective, clinical observational trial is to assess the incidence of pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in patients undergoing craniotomy surgery at three major children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the United States.
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or re-admission to the hospital. Post-operative analgesia is most commonly managed with narcotic-containing pain medication. In recent years however, there is evidence that some patients may manifest increased sensitivity to narcotics, resulting in life-threatening respiratory compromise. Though there is a theoretical risk that nonsteroidal anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation, evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains inconclusive for these generally well-tolerated medications. The goal of this study is to determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in the management of post-operative pain following pediatric adenotonsillectomy, versus more commonly used narcotic pain medication. The study design will be an initial retrospective study to collect pilot data on the incidence of postoperative hemorrhage and indicators of adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This will be followed by a prospective, randomized, single-blind controlled study in which orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone (control intervention) in the postoperative period following adenotonsillectomy.
The goal of this study is to compare different ways of treating pain after surgery. This research study involves subjects who have a supracondylar elbow fracture and need surgery. This type of fracture occurs when the humerus (upper arm bone) is broken just above the elbow. Like any other surgery, you can expect that you will feel pain in the hours or days after the operation. Currently, despite the common occurrence of this surgery, there is not a standard way to treat and or prevent any of the pain afterwards. At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after this surgery. In this study, pain will be treated in one of the following ways: 1. with oral pain medication 2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or 3. with oral pain medicine and an intraarticular shot of ropivacaine (another "numbing" drug). The shots will be given during surgery. Your participation will help us find out which of these three pain control methods works the best. The correct dosages of all drugs will be safely prescribed by the doctor on an individual basis and all drugs will be used under the careful watch of your attending physician. All the drugs used this study are approved by the FDA for use in adults but they are not specifically approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are not specifically approved by the FDA for use in children. All drugs used in this study will be used in a way that is considered to be safe and reasonable by the Children's Hospital.
This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.
The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery. * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression. Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.
The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.
This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.
The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T\&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T\&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.
The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.
To use magnesium sulfate as adjuvant analgesia by implementing a treatment protocol in order to determine whether can benefit pediatric pain in post-operative transplanted patients and decrease overall opioid consumption.
The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T\&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T\&A.
This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy. Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment. Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. Adequate pain control after surgery is pivotal for these patients in order to prevent negative physiologic and psychologic complications and to improve surgical outcomes. There is an ongoing shift away from the use of opioids in the post-operative setting due to both their negative side effects and their high potential for dependence and abuse. A variety of new techniques of multimodal pain management have been developed and utilized in elective orthopaedic procedures. Injection of local anesthetics is becoming a widely popular technique utilized in adult arthroplasty. This technique blocks pain directly at the site of injection, and therefore can improve post-operative pain while minimizing side effects. Evidence has demonstrated this technique to be both safe and effective, resulting in reduced opioid consumption post-operatively. However, this technique has not been studied for use in pediatric patients, a population in which reduced narcotic use is equally, if not more important than in adult patients. This study is a prospective, randomized controlled trial with 2 parallel arms. The goal of this study is to assess the efficacy of a surgical-site pain injection administered in pediatric patients with cerebral palsy undergoing major hip surgery. Patients who are scheduled to undergo surgery will be randomized to either intervention (injection of a pain cocktail) or placebo (injection of normal saline). The pain cocktail includes three medications: ropivacaine (a local anesthetic), ketorolac (an anti-inflammatory medication), and epinephrine (a medication to constrict blood vessels and increase the duration of action of any co-administered medications). A surgeon who is blinded to treatment group will administer the injection at the end of the procedure, prior to the patient waking from anesthesia. The injection is in addition to our typical multi-modal pain control protocol, which includes epidural anesthesia, acetaminophen, anti-inflammatories, oral narcotics and anti-spasmodic agents. Patients will then be monitored post-operatively and pain medication consumption (both while in the hospital post-operatively and for the first two weeks following discharge), patient-reported and/or nurse-recorded pain scores, length of hospital stay, and adverse effects will be recorded. At the first post-operative visit, patients' parents will be asked to complete a survey designed to assess parent satisfaction with their child's pain management after surgery. Patients, parents, and surgeons will be blinded to treatment group allocation. Data will be collected while the patient is in the hospital, after surgery (average duration 3-4 days), and at the first post-operative visit two to three weeks after surgery.