Acute Pain Effects on Motor Skills
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Delaware
Must not be taking: Analgesics
Disqualifiers: Mental health, Cardiovascular, Neurological, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To date, the effects of pain on motor learning have not been thoroughly investigated, particularly in older adults. Broadly, the purpose of this research is to investigate the impact of acute pain on locomotor learning and its retention in older adults. The investigators hypothesize that acute pain impairs retention of locomotor learning in young and older adults and that in older adults, these deficits are worsened and are related to the degree of normal age-related cognitive decline.
Do I need to stop taking my current medications for the trial?
Yes, you will need to stop taking any analgesic medications or treatments for pain relief, except for baby aspirin used for heart health.
What data supports the effectiveness of the drug Paracetamol for acute pain effects on motor skills?
Research shows that Paracetamol (also known as acetaminophen) is effective in reducing pain after surgeries, such as cleft palate repair in children, and is widely used for its pain-relieving properties. This suggests it may help manage acute pain, which could indirectly support motor skills by reducing discomfort.
12345Is paracetamol generally safe for humans?
Paracetamol (also known as acetaminophen) is widely used and generally considered safe for short-term use in humans when taken as directed. However, long-term use may increase the risk of gastrointestinal bleeding and slightly raise blood pressure. Pregnant women should use it cautiously, as it might affect fetal development.
678910How does this drug differ from other treatments for acute pain?
This treatment uses acetaminophen, which is unique for its ability to relieve pain without the significant side effects often associated with stronger pain medications like opioids. It is also part of a 'multimodal analgesia' approach, meaning it can be combined with other pain relievers to enhance effectiveness while minimizing the need for higher doses of any single drug.
511121314Eligibility Criteria
This trial is for medically healthy young adults aged 18-35 and older adults aged 55-85 who can read, write, and speak English. They must be able to consent and attend all sessions, willing to experience experimental pain or non-painful stimulation. Young participants will be sex-matched with an older participant.Inclusion Criteria
My sex matches someone in the older adult group.
Able to read, write and speak English
Self-identifying as generally medically healthy
+3 more
Exclusion Criteria
I have had balance issues, felt dizzy, or fallen more than once in the past year.
I have numbness or weakness in my legs or the area to be treated.
Score on the GAD-7 ≥ 10
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either a pain stimulus or no stimulus to study the effects on motor learning
1 day
1 visit (in-person)
Follow-up
Participants are monitored for retention of locomotor learning and cognitive performance
24 hours
1 visit (in-person)
Participant Groups
The study investigates how acute pain affects learning new motor skills like walking in both young and older adults. It looks at whether pain changes how well they remember these skills later on, especially if cognitive decline due to aging plays a role.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain StimulusExperimental Treatment1 Intervention
Capsaicin combined with heat applied to intact skin
Group II: No StimulusActive Control1 Intervention
Nothing applied to skin
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of DelawareNewark, DE
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Who Is Running the Clinical Trial?
University of DelawareLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Effect of rectal diclofenac and acetaminophen alone and in combination on postoperative pain after cleft palate repair in children. [2013]Acetaminophen and diclofenac are prescribed as postoperative analgesic agents in children. However, the efficacy of their combination is not studied sufficiently. We compare the analgesic effects of acetaminophen, diclofenac, and their combination after cleft palate surgery. In this randomized clinical trial, 120 children (1.5-5 y) who were scheduled for cleft palate repair were studied. Children were randomized to receive placebo, acetaminophen (40 mg/kg), diclofenac (1 mg/kg), or acetaminophen (40 mg/kg) plus diclofenac (1 mg/kg) rectally just after surgery. Acetaminophen (30 mg/kg) and diclofenac (1 mg/kg) were administered every 8 hours until 48 hours. Postoperative pain was assessed regularly with the Children Hospital of Eastern Ontario Pain Scale, and rescue analgesia was provided if scores were 7 or greater. Time to the first prescription of meperidine, total postoperative meperidine consumption, and adverse effects were the main outcomes.After surgery, pain scores were higher in placebo than in other groups in all time intervals. In the first 12 hours, pain scores in the combined group were less than those in the acetaminophen (P
A randomized, double-blind, placebo-controlled trial of paracetamol and ketoprofren lysine salt for pain control in children with pharyngotonsillitis cared by family pediatricians. [2021]To evaluate the analgesic effect and tolerability of paracetamol syrup compared to placebo and ketoprofen lysine salt in children with pharyngotonsillitis cared by family pediatricians.
[Paracetamol. Present status of knowledge in 1989]. [2013]Today paracetamol (acetaminophen), the oldest known synthetic analgesic-antipyretic drug, is one of the most frequently used around the world. The present general review presents the essential knowledge about this drug which has accumulated during the last decade, 1978 from to 1988. It includes recent data concerning toxicity, pharmacokinetics, mechanisms of analgesic and antipyretic action, and therapeutic efficacy. Readers interested in the original papers are referred to 264 bibliographical references.
[Efficacy of propacetamol in postoperative pain based on two modes of intravenous administration]. [2013]The analgesic and antipyretic efficacy of propacetamol is identical to paracetamol. Because the propacetamol is injectable and its side effects are uncommon and mild, it is the drug commonly used in France for postoperative pain relief. The aim of this prospective study was to compare the analgesic efficacy of propacetamol after breast surgery or thyroidectomy when it was administered either systematically or on the patients demand. After informed consent, 119 patients having undergone breast surgery or thyroidectomy, having received the same general anaesthesia and scheduled for receiving propacetamol postoperatively, were included in the study. Two groups of patients were compared, those who received propacetamol on demand (D Group) and those who received propacetamol systematically (S Group). During the first 24 hours, analgesia was evaluated on a visual analogical scale graded from 0 to 100 mm, at rest and during mobilization; the efficacy was also evaluated by the amount of additional analgesic drug injected. Side effects were also compared between the 2 treatment groups. In the 2 groups, demographic data, type of anaesthesia and type of surgery were identical. Postoperative pain relief and supplemental injection of morphine were not statistically different between the 2 groups. Propacetamol doses were statistically higher in the S group than in the D group (7.8 +/- 0.7 g and 3.9 +/- 2.3 g respectively, p
Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers. [2018]Acetaminophen (APAP, paracetamol) mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467) was carried out from May 30, 2011 to July 12, 2011.
Paracetamol for the management of pain in inflammatory arthritis: a systematic literature review. [2018]To systematically review the literature on the efficacy and safety of paracetamol (acetaminophen) in the management of pain in inflammatory arthritis.
Paracetamol use during pregnancy - a call for precautionary action. [2022]Paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) is the active ingredient in more than 600 medications used to relieve mild to moderate pain and reduce fever. APAP is widely used by pregnant women as governmental agencies, including the FDA and EMA, have long considered APAP appropriate for use during pregnancy when used as directed. However, increasing experimental and epidemiological research suggests that prenatal exposure to APAP might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders. Here we summarize this evidence and call for precautionary action through a focused research effort and by increasing awareness among health professionals and pregnant women. APAP is an important medication and alternatives for treatment of high fever and severe pain are limited. We recommend that pregnant women should be cautioned at the beginning of pregnancy to: forego APAP unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time. We suggest specific actions to implement these recommendations. This Consensus Statement reflects our concerns and is currently supported by 91 scientists, clinicians and public health professionals from across the globe.
Treatment of acute migraine attacks in children with analgesics on the World Health Organization Essential Medicines List: A systematic review and GRADE evidence synthesis. [2019]Background The World Health Organization Essential Medicines List (WHO EML) contains two analgesics for treatment of acute migraine attacks in children, ibuprofen and paracetamol. Methods The Embase, CDSR, CENTRAL, DARE and MEDLINE databases were searched up to 18 April 2017. We analyzed randomized controlled trials (RCTs) and systematic reviews (SRs) that investigate the efficacy and safety of ibuprofen or paracetamol for treatment of acute migraine attacks in children. We conducted meta-analysis and assessments of evidence with GRADE, Cochrane risk of bias tool, and AMSTAR. Results Three RCTs (201 children) and 10 SRs on ibuprofen and/or paracetamol for acute migraine attacks in children were included. Meta-analysis indicated that ibuprofen was superior to placebo for pain-free at 2 h or pain relief at 2 h, without difference in adverse events. There were no differences between paracetamol and placebo, or ibuprofen and paracetamol. Ten SRs that analyzed various therapies for migraine in children were published between 2004 and 2016, with discordant conclusions. Conclusion Limited data from poor quality RCTs indicate that ibuprofen and paracetamol might be effective analgesics for treating migraine attacks in children. Inclusion of ibuprofen and paracetamol as antimigraine medicines for children in the WHO EML is supported by indirect evidence from studies in adults.
Use of paracetamol, ibuprofen or aspirin in pregnancy and risk of cerebral palsy in the child. [2019]It has been debated whether mild analgesics, mainly paracetamol, adversely affect aspects of neurodevelopment. We examined whether mother's use of paracetamol, aspirin or ibuprofen in pregnancy is associated with increased risk of cerebral palsy (CP) in the child.
Long-term adverse effects of paracetamol - a review. [2023]Paracetamol (acetaminophen) is the most commonly used drug in the world, with a long record of use in acute and chronic pain. In recent years, the benefits of paracetamol use in chronic conditions has been questioned, notably in the areas of osteoarthritis and lower back pain. Over the same period, concerns over the long-term adverse effects of paracetamol use have increased, initially in the field of hypertension, but more recently in other areas as well. The evidence base for the adverse effects of chronic paracetamol use consists of many cohort and observational studies, with few randomized controlled trials, many of which contradict each other, so these studies must be interpreted with caution. Nevertheless, there are some areas where the evidence for harm is more robust, and if a clinician is starting paracetamol with the expectation of chronic use it might be advisable to discuss these side effects with patients beforehand. In particular, an increased risk of gastrointestinal bleeding and a small (~4 mmHg) increase in systolic blood pressure are adverse effects for which the evidence is particularly strong, and which show a degree of dose dependence. As our estimation of the benefits decreases, an accurate assessment of the harms is ever more important. The present review summarizes the current evidence on the harms associated with chronic paracetamol use, focusing on cardiovascular disease, asthma and renal injury, and the effects of in utero exposure.
[Role of paracetamol in the acute pain management]. [2019]Paracetamol (acetaminophen) has been shown to be an effective analgesic for the treatment of moderate pain where it is chiefly indicated, as shown in placebo-controlled studies in the perioperative setting and other acute pain states. In addition, an opioid-sparing effect has been demonstrated. No clinically relevant adverse effects are usually apparent with recommended doses. Paracetamol is an effective component in 'multimodal analgesia' in combination with morphine, weak opioids and non-steroidal anti-inflammatory drugs. Although most studies involve the perioperative setting, similar results have been obtained in other acute pain states, such as acute musculoskeletal pain, migraine, etc. In conclusion, paracetamol has a favourable efficacy-tolerability profile and is therefore recommended as a basic, first-line analgesic in acute pain states and as a valuable component in multimodal analgesia.
Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. [2013]This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain.
Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies. [2022]Acetaminophen (paracetamol, APAP) is widely used to relieve mild-to-moderate pain and reduce fever. Absorption of the drug can be impacted by dosage form; this may have implications for pain relief in some individuals, potentially accounting for suboptimal efficacy in analgesia.
Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. [2013]Paracetamol (APAP), also known as acetaminophen, is the most commonly used over-the-counter analgesic for the treatment of mild-to-moderate pain. However, the speed of onset of pain relief is limited mainly to the standard, immediate-release formulation. Efficacy and speed of onset of pain relief are critical in acute pain situations such as postsurgical dental pain, because reducing pain can improve clinical outcome and reduce the risk of transition from acute pain to more chronic pain. Efficacy and rapid onset also reduce the risk of excessive dosing with the analgesic.